2009 Cancer M EDICINES IN D EVELOPMENT FOR Report P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L R E S E A R C H C O M PA N I E S F ew things cause patients more fear and uncertainty than a cancer diagnosis. But today—because of a steady stream of new and improved medicines and treatments—cancer increasingly can be managed and even beaten. President Obama has called for a cancer cure in our lifetime, patients and their families are looking for more and better treatments, and America’s pharmaceutical research and biotechnology companies are responding. Pharmaceutical researchers are now working on 861 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research on using existing medicines in new ways. The medicines in development—all in either clinical trials or under Food and Drug Administration review— include 122 for lung cancer, the leading cause of cancer death in the United States; 106 for breast cancer, which is expected to strike more than 180,000 American women each year; 103 for prostate cancer, which is expected to kill more than 28,000 American men each year; and 70 for colorectal cancer, the third most common cancer in both men and women in this country. Additional medicines target brain cancer, kidney cancer, leukemia, ovarian cancer, pancreatic cancer, skin cancer, and others. In addition, companies are working on medicines to improve the quality of life for cancer patients. This commitment to patients and research is at the core of the remarkable progress made in the past decade fighting cancer that has led to declines in both cancer cases and cancer deaths. Death rates for eight of the top 10 cancers remained level or declined during the 1990s, according to a Journal of the National Cancer Institute report. America’s pharmaceutical research companies are working on many new cutting edge approaches to fight cancer. They include: • A medicine that inhibits production of a protein that may interfere with the effectiveness of chemotherapy. • A drug that delivers a synthetic version of a substance derived from scorpions directly to brain tumor cells. • A medicine designed to induce a powerful immune response to melanoma. • A potential first-line treatment (meaning it’s given to patients before any other treatment) and first-in-class medicine designed to target specific cancer cells and kill them, then activate the patient’s general immune system to destroy any remaining cancer cells. • One therapy in development uses new nanotech- nology that enhances the delivery of medicine to the patient, overcoming obstacles in existing treatments. Despite progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart disease. In 2008, some 565,650 Americans were expected to die of cancer—more than 1,500 people a day. The hundreds of new medicines to treat cancer now being developed by the pharmaceutical research industry demonstrate our commitment to meeting patient needs. They are our best hope for stemming the toll of cancer-related deaths. Billy Tauzin President and CEO PhRMA More Than 800 Medicines and Vaccines in Testing Offer Hope in the Fight Against Cancer M EDICINES IN D EVELOPMENT FOR C ANCER * *Some medicines are listed in more than one category. Unspecified Cancers Other Cancers Cancer-Related Conditions Stomach Cancer Solid Tumors Skin Cancer Sarcoma Prostate Cancer Pancreatic Cancer Ovarian Cancer Multiple Myeloma Lymphoma Lung Cancer Liver Cancer Leukemia Kidney Cancer Head/Neck Cancer Colorectal Cancer Cervical Cancer Breast Cancer Brain Cancer Bladder Cancer 23 61 106 13 70 34 44 129 35 122 99 52 63 54 103 27 67 203 27 51 55 74
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Drugs in Development for Different Cancers_ 2009 Report
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2009
CancerM E D I C I N E S I N D E V E L O P M E N T F O R
Report
P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L R E S E A R C H C O M P A N I E S
Few things cause patients more fear and uncertaintythan a cancer diagnosis. But today—because of asteady stream of new and improved medicines and
treatments—cancer increasingly can be managed and evenbeaten. President Obama has called for a cancer cure inour lifetime, patients and their families are looking for moreand better treatments, and America’s pharma ceuticalresearch and biotechnology companies are responding.
Pharmaceutical researchers are now working on861 medicines for cancer. Many are high-tech weaponsto fight the disease, while some involve innovativeresearch on using existing medicines in new ways.
The medicines in development—all in either clinicaltrials or under Food and Drug Administration review—include 122 for lung cancer, the leading cause of cancerdeath in the United States; 106 for breast cancer, which isexpected to strike more than 180,000 American womeneach year; 103 for prostate cancer, which is expected tokill more than 28,000 American men each year; and70 for colorectal cancer, the third most common cancerin both men and women in this country. Additionalmedicines target brain cancer, kidney cancer, leukemia,ovarian cancer, pancreatic cancer, skin cancer, andothers. In addition, companies are working on medicinesto improve the quality of life for cancer patients.
This commitment to patients and research is at the coreof the remarkable progress made in the past decade fightingcancer that has led to declines in both cancer cases andcancer deaths. Death rates for eight of the top 10 cancersremained level or declined during the 1990s, accordingto a Journal of the National Cancer Institute report.
America’s pharmaceutical research companies areworking on many new cutting edge approaches to fightcancer. They include:
• A medicine that inhibits production of a protein thatmay interfere with the effectiveness of chemotherapy.
• A drug that delivers a synthetic version of a substancederived from scorpions directly to brain tumor cells.
• A medicine designed to induce a powerful immuneresponse to melanoma.
• A potential first-line treatment (meaning it’s given topatients before any other treatment) and first-in-classmedicine designed to target specific cancer cells andkill them, then activate the patient’s general immunesystem to destroy any remaining cancer cells.
• One therapy in development uses new nanotech -nology that enhances the delivery of medicine tothe patient, overcoming obstacles in existingtreatments.
Despite progress, cancer remains the second leadingcause of death by disease in the United States, exceededonly by heart disease. In 2008, some 565,650 Americanswere expected to die of cancer—more than 1,500 peoplea day. The hundreds of new medicines to treat cancernow being developed by the pharma ceutical researchindustry demonstrate our commitment to meeting patientneeds. They are our best hope for stemming the toll ofcancer-related deaths.
Billy TauzinPresident and CEOPhRMA
More Than 800 Medicines and Vaccines in TestingOffer Hope in the Fight Against Cancer
MEDICINES IN DEVELOPMENT FOR CANCER*
*Some medicines are l is ted in more than one category.
Unspecified CancersOther Cancers
Cancer-Related Conditions
Stomach CancerSolid Tumors
Skin CancerSarcoma
Prostate CancerPancreatic Cancer
Ovarian Cancer
Multiple MyelomaLymphoma
Lung Cancer
Liver CancerLeukemia
Kidney CancerHead/Neck CancerColorectal Cancer
Cervical CancerBreast CancerBrain Cancer
Bladder Cancer 23
61106
1370
34
44
12935
12299
52
63
54103
2767
20327
51
5574
2 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
Medicines in Development for CancerB L A D D E R C A N C E RProduct Name Sponsor Indication Development Status*
Advexin® Introgen Therapeutics (see also brain, breast, head/neck, Phase Icontusugene Austin, TX lung, ovarian, prostate, stomach) (512) 708-9310ladenovec
BC-819 BioCancell Therapeutics Phase IIJerusalem, Israel
belinostat Topo Target USA combination therapy Phase IIRockaway, NJ (see also colorectal, leukemia, (973) 895-6900
liver, lung, lymphoma, ovarian)
CDX-1307 Celldex Therapeutics (see also breast, colorectal, ovarian, Phase INeedham, MA pancreatic) (781) 433-0771
Celebrex® Pfizer (see also prostate) Phase IIIcelecoxib New York, NY (860) 732-5156
CG0070 Cell Genesys Phase ISouth San Francisco, CA (650) 266-3000Novartis Pharmaceuticals (888) 669-6682East Hanover, NJ
Chemophase™ Halozyme Therapeutics superficial bladder cancer Phase I/IIhyaluronidase San Diego, CA (858) 794-8889
EOquin® Spectrum Pharmaceuticals Phase IIIapaziquone Irvine, CA (949) 788-6700
Erbitux® Bristol-Myers Squibb (see also colorectal, head/neck, Phase IIcetuximab Princeton, NJ lung, prostate, stomach) (212) 546-4000
Eli Lilly (800) 545-5979Indianapolis, IN (212) 645-1405ImClone SystemsNew York, NY
Hexvix® GE Healthcare diagnostic imaging of application submittedhexyl Waukesha, WI bladder canceraminolevulinate
Iressa® AstraZeneca (see also brain) Phase IIgefitinib Wilmington, DE (800) 236-9933
larotaxel sanofi-aventis (see also pancreatic) Phase III(XRP9881) Bridgewater, NJ (800) 633-1810
Levulan® PD DUSA Pharmaceuticals (see also cervical, colorectal, lung, Phase I/IIaminolevulinic acid Wilmington, MA stomach) (978) 657-7500
Armala™ GlaxoSmithKline glioma Phase IIpazopanib Rsch. Triangle Park, NC (see also breast, cervical, kidney, (888) 825-5249
liver, lung, ovarian, sarcoma, other)
4 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R A I N C A N C E RProduct Name Sponsor Indication Development Status
Avastin® Genentech glioblastoma application submittedbevacizumab South San Francisco, CA (see also colorectal, head/neck, (650) 225-1000
kidney, liver, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, stomach, other)-------------------------------------------------------------------------------------------metastatic brain cancer from Phase IINSCLC (650) 225-1000
Azedra™ Molecular Insight neuroblastoma in children Phase IIiodine-labeled Pharmaceuticals (see also other) (617) 492-5554metaiodobenzyl- Cambridge, MAguanidine
Azixa™ Myriad Pharmaceuticals glioblastoma, metastatic brain cancer Phase II(MPC-6827) Salt Lake City, UT (see also skin) (801) 584-3600
banoxantrone Transcept Pharmaceuticals glioblastoma Phase I/IIPt. Richmond, CA (510) 215-3500
OncoGel® Protherics glioblastoma Phase I/IIBrentwood, TN (see also pancreatic, stomach) (615) 327-1027
Oncophage® Antigenics glioma Phase IIvitespan New York, NY (see also colorectal, kidney, (866) 805-8994
pancreatic, skin, stomach)
panobinostat Novartis Pharmaceuticals glioma Phase I/IIEast Hanover, NJ (see also breast, leukemia, (888) 669-6682
lymphoma, prostate)
6 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R A I N C A N C E RProduct Name Sponsor Indication Development Status
patupilone Novartis Pharmaceuticals (see also breast, colorectal, liver, Phase II(EPO906) East Hanover, NJ lung, ovarian) (888) 669-6682
perifosine AEterna Zentaris glioma Phase IIMontreal, Canada (see also head/neck, kidney, (212) 531-5965Keryx Biopharmaceuticals lymphoma, multiple myeloma, New York, NY ovarian, sarcoma)
PRX-321 Protox Therapeutics glioblastoma Phase II(Orphan Drug) Vancouver, Canada (see also solid tumors) (604) 688-0199
Reolysin® Oncolytics Biotech glioma Phase I/IIreovirus Calgary, Canada (see also head/neck, lung, sarcoma, (403) 670-7377
skin)
sagopilone Bayer HealthCare (see also breast, ovarian, prostate) Phase IIPharmaceuticals (888) 842-2937Wayne, NJ
tandutinib Millennium glioma Phase II(MLN0518) Pharmaceuticals (see also prostate) (800) 390-5663
Cambridge, MA --------------------------------------------------------------------------------------gliobastoma Phase I/II
(800) 390-5663
Tarceva® Genentech glioblastoma Phase IIerlotinib South San Francisco, CA (see also bladder, breast, colorectal, (650) 225-1000(Orphan Drug) OSI Pharmaceuticals head/neck, liver, lung, other) (800) 572-1932
Melville, NY
terameprocol Erimos Pharmaceuticals glioma Phase I/IIHouston, TX (see also cervical, head/neck) (713) 541-2000
TheraCIM™ YM Biosciences glioma (pediatric) Phase IInimotuzumab Wayne, PA (see also breast, prostate, stomach) (610) 560-0600(Orphan Drug)
Trisenox® Cephalon glioma Phase Iarsenic trioxide Frazer, PA (see also leukemia, multiple myeloma) (610) 344-0200
Tykerb® GlaxoSmithKline brain metastases from breast cancer Phase IIIlapatinib Rsch. Triangle Park, NC (see also head/neck, stomach) (888) 825-5249
7M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R A I N C A N C E RProduct Name Sponsor Indication Development Status
VP101 Access Pharmaceuticals glioblastoma Phase II(Orphan Drug) Dallas, TX (see also colorectal, leukemia, (214) 905-5100
prostate)
Xcytrin® Pharmacyclics brain metastases from non-small-cell application submittedmotexafin Sunnyvale, CA lung cancer (408) 774-0330gadolinium (see also kidney, leukemia, lung,
lymphoma) --------------------------------------------------------------------------------------glioma (combination therapy) Phase II
(408) 774-0330--------------------------------------------------------------------------------------glioblastoma (combination therapy) Phase I
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
ABI-008 Abraxis BioScience metastatic breast cancer Phase I/IILos Angeles, CA (see also prostate) (310) 883-1300
ABT-751 Abbott Laboratories (see also colorectal, kidney, lung) Phase IIAbbott Park, IL (847) 937-6100
ABT-869 Abbott Laboratories combination therapy Phase IIAbbott Park, IL (see also kidney, liver, lung) (847) 937-6100Genentech (650) 225-1000South San Francisco, CA
aderbasib Incyte combination therapy Phase II(INCB7839) Wilmington, DE (302) 498-6700
Advexin® Introgen Therapeutics combination therapy Phase IIcontusugene Austin, TX (see also bladder, brain, head/neck, (512) 708-9310ladenovec lung, ovarian, prostate, stomach)
8 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
AE-37 Antigen Express (see also ovarian) Phase IIWorcester, MA (508) 852-8783
AG-14699 Pfizer (see also ovarian) Phase IINew York, NY (860) 732-5156
Alimta® Eli Lilly (see also head/neck, lung, ovarian) Phase IIpemetrexed Indianapolis, IN (800) 545-5979
AMG 386 Amgen (see also kidney, ovarian, Phase IIThousand Oaks, CA stomach, other) (805) 447-1000
AMG 479 Amgen (see also colorectal, lung, Phase IIThousand Oaks, CA pancreatic, sarcoma) (805) 447-1000
Amplimexon® AmpliMed (see also lung, multiple myeloma, Phase Iimexon Tucson, AZ pancreatic, prostate, skin) (520) 529-1000
anti-CD3 TransTarget metastatic breast cancer Phase Iactivated T-cells Hillsborough, CA
anti-MUC1 mAb Paladin Labs (see also multiple myeloma, Phase I completedSt. Laurent, Canada pancreatic) (888) 376-7830
anti-PEM mAb Access Pharmaceuticals Phase I/IIDallas, TX (214) 905-5100
Armala™ GlaxoSmithKline combination therapy Phase IIIpazopanib Rsch. Triangle Park, NC (see also brain, cervical, kidney, (888) 825-5249
liver, lung, ovarian, sarcoma, other)
Aromasin® Pfizer breast cancer prevention Phase IIIexemestane New York, NY (860) 732-5156
ARRY-543 Array BioPharma combination therapy Phase I/IIBoulder, CO (303) 381-6600
arzoxifene Eli Lilly invasive breast cancer risk reduction Phase IIIIndianapolis, IN (800) 545-5979
AS-1402 Antisoma Phase IICambridge, MA (617) 225-0522
AVE1642 sanofi-aventis hormonal-sensitive breast cancer Phase II(anti-IGF-1R mAb) Bridgewater, NJ (800) 633-1810
AZD2281 AstraZeneca monotherapy Phase IIWilmington, DE (see also ovarian) (800) 236-9933
IMC-1121B Eli Lilly (see also colorectal, kidney, liver, Phase IIIIndianapolis, IN lung, ovarian, prostate, skin) (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-A12 Eli Lilly (see also colorectal, head/neck, Phase IIIndianapolis, IN liver, lung, pancreatic, prostate, (800) 545-5979ImClone Systems sarcoma, solid tumors) (212) 645-1045New York, NY
IMT-1012 ImmunoVaccine (see also ovarian) Phase ITechnologies (902) 492-1819Halifax, Canada
INGN 225 Introgen Therapeutics (see also lung) Phase I/II(p53 vaccine) Austin, TX (512) 708-9310
ispinesib CytoKinetics (see also colorectal, kidney, Phase IISouth San Francisco, CA leukemia) (650) 624-3000
Ixempra™ Bristol-Myers Squibb early breast cancer in clinical trialsixabepilone Princeton, NJ (see also lung, pancreatic, prostate) (212) 546-4000
lapuleucel-T Dendreon (see also colorectal, ovarian) Phase I completedSeattle, WA (206) 256-4545
LEP-ETU NeoPharm Phase IILake Bluff, IL (847) 887-0800
LOR-2040 Lorus Therapeutics metastatic breast cancer Phase IIToronto, Canada (see also colorectal, kidney, (416) 798-1200
leukemia)
Lymphoseek™ Neoprobe diagnosis of breast cancer Phase IIIDublin, OH (see also skin) (800) 793-0079
milataxel Taxolog (see also colorectal, lung) Phase IIFairfield, NJ (877) 829-6564
MK-0646 Merck (see also lung, pancreatic, other) Phase IWhitehouse Station, NJ (800) 672-6372
11M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
MK-0752 Merck (see also leukemia) Phase IWhitehouse Station, NJ (800) 672-6372
MKC 1 EntreMed metastatic breast cancer Phase II completedRockville, MD (see also leukemia, lung, pancreatic) (240) 864-2600
motesanib Amgen combination therapy Phase IIThousand Oaks, CA (see also colorectal, lung, other) (805) 447-1000Millennium (800) 390-5663PharmaceuticalsCambridge, MA
NBI-42902 Neurocrine Biosciences (see also prostate, other) Phase ISan Diego, CA (858) 617-7600
neratinib Wyeth Pharmaceuticals monotherapy Phase III(HKI272) Collegeville, PA (see also lung) (800) 934-5556
NeuVax™ Apthera (see also prostate) Phase IIE75 cancer Scottsdale, AZ (480) 882-8841vaccine
Nexavar® Bayer HealthCare combination therapy Phase IIsorafenib Pharmaceuticals (see also lung, skin) (888) 842-2937
Wayne, NJ (510) 597-6500Onyx PharmaceuticalsEmeryville, CA
NOV-002 Novelos Therapeutics early-stage breast cancer Phase IINewton, MA (see also lung, ovarian) (617) 244-1616
OBP-301 Oncolys Biopharma (see also head/neck, lung) Phase ITokyo, Japan www.oncolys.com
OGX-427 Oncogenex (see also bladder, lung, ovarian, Phase IPharmaceuticals prostate) (425) 686-1500Bothell, WA
OPT-22 Optimer Pharmaceuticals Phase ISan Diego, CA (858) 909-0736
panobinostat Novartis Pharmaceuticals (see also brain, leukemia, Phase I/IIEast Hanover, NJ lymphoma, prostate) (888) 669-6682
patupilone Novartis Pharmaceuticals (see also brain, colorectal, liver, Phase II(EPO906) East Hanover, NJ lung, ovarian) (888) 669-6682
PD-332991 Pfizer combination therapy, Phase I/IINew York, NY first-line therapy (860) 732-5156
(see also lymphoma, multiple myeloma)
pertuzumab Genentech first-line therapy, metastatic Phase IIISouth San Francisco, CA breast cancer (650) 224-1000
(see also ovarian)
PTC-299 PTC Therapeutics (see also skin) Phase I/IISouth Plainfield, NJ (908) 222-7000
12 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
PX-1032 BN ImmunoTherapeutics Phase I/II(HER2 breast Mountain View, CA (650) 681-4660cancer vaccine) Pharmexa
Horsholm, Denmark
Quinamed® ChemGenex (see also ovarian, prostate) Phase IIamonafide Pharmaceuticals (650) 474-9800
Menlo Park, CA
R1507 Roche combination therapy Phase IINutley, NJ (see also lung, lymphoma, sarcoma) (973) 235-5000
retaspimycin Infinity Pharmaceuticals (see also lung, stomach) Phase II(IPI 504) Cambridge, MA (617) 453-1000
Reximmune-C™ Epeius Biotechnologies Phase I/IISan Marino, CA (626) 441-6695
Rexin-G™ Epeius Biotechnologies recurrent, refractory metastatic Phase I/IItumor-targeted San Marino, CA breast cancer (626) 441-6695gene therapy (see also pancreatic, sarcoma)
sagopilone Bayer HealthCare (see also brain, ovarian, prostate) Phase IIPharmaceuticals (888) 842-2937Wayne, NJ
Sarasar™ Schering-Plough (see also leukemia, pancreatic) Phase IIlonafarnib Kenilworth, NJ (908) 298-4000
satraplatin Spectrum Pharmaceuticals metastatic breast cancer, Phase II completedIrvine, CA second-line therapy (949) 788-6700
(see also lung, prostate)
SCH-727965 Schering-Plough (see also leukemia, lung) Phase IIKenilworth, NJ (908) 298-4000
SF1 SonneMed advanced breast cancer Phase I/IIBoston, MA
SNDX-275 Syndax Pharmaceuticals (see also lung) Phase IIWaltham, MA (781) 839-7301
SU-14813 Pfizer Phase IINew York, NY (860) 732-5156
Sutent® Pfizer (see also colorectal, liver, lung, Phase IIIsunitinib New York, NY pancreatic, prostate, sarcoma, (860) 732-5156
stomach)
TamoGel™ ASCEND Therapeutics Phase IIafimoxifene Herndon, VA (703) 471-4744
Tarceva® Genentech (see also bladder, brain, colorectal, Phase IIerlotinib South San Francisco, CA head/neck, liver, lung, other) (650) 224-1000
OSI Pharmaceuticals (800) 572-1932Melville, NY
TAS-108 Taiho Pharma USA Phase IIPrinceton, NJ (609) 750-5300
Telcyta™ Telik (see also colorectal, lung, ovarian) Phase II completedcanfosfamide Palo Alto, CA (650) 845-7700
13M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
tesmilifene YM BioSciences (see also prostate) Phase IIIWayne, PA (610) 560-0600
TheraCIM™ YM Biosciences adjunctive treatment Phase Inimotuzumab Wayne, PA (see also brain, prostate, stomach) (610) 560-0600
Thermodox™ Celsion locally recurrent breast cancer Phase I/IILTSDEL Columbia, MD (see also liver) (410) 290-5390
trastuzumab-DM1 Genentech metastatic breast cancer Phase IIISouth San Francisco, CA (second-line therapy) (650) 225-1000ImmunoGen (781) 895-0600Waltham, MA --------------------------------------------------------------------------------------
metastatic breast cancer Phase II(first-line therapy, third-line therapy) (650) 225-1000
(781) 895-0600
Trelstar® Watson Pharmaceuticals Phase IIItriptorelin Corona, CA (951) 493-5300
tremelimumab Pfizer (see also colorectal, kidney, lung, Phase INew York, NY prostate, skin) (860) 732-5156
trilostane Genzyme (see also prostate) in clinical trialsCambridge, MA (617) 252-7500
vinflunine Pierre Fabre advanced breast cancer Phase IIIPharmaceuticals (see also bladder) (973) 898-1042Parsippany, NJ
AVX701 AlphaVax colorectal cancer prevention Phase I/IIRsch. Triangle Park, NC (919) 595-0400
axitinib Pfizer combination first-line therapy Phase IINew York, NY (see also kidney, lung, solid tumors, (860) 732-5156
other)--------------------------------------------------------------------------------------metastatic colorectal cancer Phase II(combination second-line therapy) (860) 732-5156
belinostat TopoTarget USA (see also bladder, leukemia, Phase IRockaway, NJ liver, lung, lymphoma, ovarian) (973) 895-6900
brivanib Bristol-Myers Squibb metastatic colorectal cancer Phase III(VEGFR/FGFR Princeton, NJ (combination with cetuximab) (212) 546-4000kinase inhibitor) (see also liver)
CDX-1307 Celldex Therapeutics (see also bladder, breast, ovarian, Phase INeedham, MA pancreatic) (781) 433-0771
conatumumab Amgen (see also lung, pancreatic, sarcoma) Phase IIThousand Oaks, CA (805) 447-1000
CP-751871 Pfizer (see also breast, lung, multiple Phase IINew York, NY myeloma, prostate, sarcoma) (860) 732-5156
Eli Lilly (see also bladder, head/neck, lung, (800) 545-5979Indianapolis, IN prostate, stomach) (212) 645-1405ImClone Systems --------------------------------------------------------------------------------------New York, NY rectal cancer Phase II
(212) 546-4000(800) 545-5979(212) 645-1405
Fusilev™ Spectrum Pharmaceuticals (see also sarcoma) application submittedlevoleucovorin Irvine, CA (949) 788-6700for injection
Herceptin® Genentech (see also ovarian, pancreatic, Phase IItrastuzumab South San Francisco, CA prostate, stomach, other) (650) 225-1000
huA33 Life Science Phase IPharmaceuticals (203) 422-6500Greenwich, CT
Hycamtin® GlaxoSmithKline (see also breast, head/neck, kidney, Phase IItopotecan Rsch. Triangle Park, NC leukemia, lung, lymphoma, multiple (888) 825-5249
IMC-1121B Eli Lilly (see also breast, kidney, liver, lung, Phase IIIndianapolis, IN ovarian, prostate, skin) (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-A12 Eli Lilly (see also breast, head/neck, liver, Phase IIIndianapolis, IN lung, pancreatic, prostate, sarcoma, (800) 545-5979ImClone Systems solid tumors) (212) 645-1405New York, NY
IMO-2055 Idera Pharmaceuticals combination therapy Phase ICambridge, MA (see also kidney, lung) (617) 679-5500
ispinesib CytoKinetics (see also breast, kidney, leukemia) Phase IISouth San Francisco, CA (650) 624-3000
KRN-330 Kirin Pharma USA Phase ILa Jolla, CA (858) 952-7000
KRX-0402 Keryx Biopharmaceuticals (see also brain, kidney, Phase INew York, NY multiple myeloma, sarcoma) (212) 531-5965
lapuleucel-T Dendreon (see also breast, ovarian) Phase I completedSeattle, WA (206) 256-4545
LE-SN38 NeoPharm second-line therapy Phase IILake Bluff, IL (847) 887-0800
Levulan® PD DUSA Pharmaceuticals (see also bladder, cervical, lung, in clinical trialsaminolevulinic acid Wilmington, MA stomach) (978) 657-7500
Litx™ Light Sciences Oncology metastatic colorectal cancer Phase IIItalaporfin Bellevue, WA (425) 957-8900
LOR-2040 Lorus Therapeutics metastatic colorectal cancer Phase IIToronto, Canada (see also breast, kidney, leukemia) (416) 798-1200
17M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
C O L O R E C T A L C A N C E RProduct Name Sponsor Indication Development Status
milataxel Taxolog (see also breast, lung) Phase IIFairfield, NJ (877) 829-6564
motesanib Amgen metastatic colorectal cancer Phase IThousand Oaks, CA (combination therapy) (805) 447-1000Millennium (see also breast, lung, other) (800) 390-5663PharmaceuticalsCambridge, MA
NKTR-102 Nektar Therapeutics combination, second-line therapy Phase IISan Carlos, CA (see also ovarian) (650) 631-3100
Oncophage® Antigenics (see also brain, kidney, pancreatic, Phase IIvitespen New York, NY skin, stomach) (866) 805-8994
OncoVAX® Vaccinogen stage III colorectal cancer Phase IIcancer vaccine Frederick, MD (combination therapy) (301) 668-8400
(see also kidney, skin)--------------------------------------------------------------------------------------colorectal cancer Phase I/II
(301) 668-8400
patupilone Novartis Pharmaceuticals (see also brain, breast, liver, lung, Phase I/II(EPO906) East Hanover, NJ ovarian) (888) 669-6682
pelitinib Wyeth Pharmaceuticals second-line therapy Phase II(EKB569) Collegeville, PA (see also lung) (800) 934-5556
picoplatin Poniard Pharmaceuticals (see also lung) Phase IISeattle, WA (206) 281-7001
PN401 Wellstat Therapeutics (see also pancreatic, stomach) Phase IGaithersburg, MD (240) 631-2500
PV701 Wellstat Biologics (see also cervical) Phase IIGaithersburg, MD (240) 631-2500
RIGScan® CR49 Neoprobe diagnosis of colorectal cancer Phase IIIradiodiagnostic Dublin, OH (800) 793-0079agent
IMC-A12 Eli Lilly (see also breast, colorectal, liver, Phase IIIndianapolis, IN lung, pancreatic, prostate, sarcoma, (800) 545-5979ImClone Systems solid tumors) (212) 645-1405New York, NY
ING 234 Colgate-Palmolive orofacial cancer (prevention) Phase II(mouthwash) New York, NY (512) 708-9310
Introgen TherapeuticsAustin, TX
INGN 241 Introgen Therapeutics combination therapy Phase III(mda-7) Austin, TX (see also skin) (512) 708-9310
IRX-2 IRX Therapeutics Phase IINew York, NY (212) 582-1199
20 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
H E A D / N E C K C A N C E RProduct Name Sponsor Indication Development Status
Multikine® CEL-SCI (see also cervical) Phase IIleukocyte Vienna, VA (703) 506-9460interleukin
OBP-301 Oncolys Biopharma (see also breast, lung) Phase ITokyo, Japan www.oncolys.com
perifosine AEterna Zentaris (see also brain, kidney, lymphoma, Phase IIMontreal, Canada multiple myeloma, ovarian, (212) 531-5965Keryx Biopharmaceuticals sarcoma)New York, NY
Reolysin® Oncolytics Biotech combination therapy Phase IIreovirus Calgary, Canada (see also brain, lung, sarcoma, skin) (403) 670-7377
SCH-58500 Schering-Plough (see also bladder, liver, Phase I(p53 gene therapy) Kenilworth, NJ lung, cancer-related) (908) 298-4000
sibrotuzumab Life Science (see also colorectal, lung) Phase IIPharmaceuticals (203) 422-6500Greenwich, CT
Tarceva® Genentech resected head/neck squamous Phase IIIerlotinib South San Francisco, CA cell cancer (650) 224-1000
OSI Pharmaceuticals (see also bladder, brain, breast, (800) 572-1932Melville, NY colorectal, liver, lung, other)
TAS-106 Taiho Pharma USA Phase IIPrinceton, NJ (609) 750-5300
tegafur/uracil EMD Serono (see also colorectal) Phase IIcombination Rockland, MA (800) 283-8088
terameprocol Erimos Pharmaceuticals (see also brain, cervical) Phase IHouston, TX (713) 541-2000
Thymitaq® YM BioSciences (see also colorectal, liver, lung, Phase IInolatrexed Wayne, PA pancreatic, prostate) (610) 560-0600
TNFerade™ GenVec (see also colorectal, pancreatic, skin, Phase I/IIGaithersburg, MD stomach) (240) 632-0740
Tykerb® GlaxoSmithKline (see also brain, stomach) Phase IIIlapatinib Rsch. Triangle Park, NC (888) 825-5249
VB-4845 Viventia Biotech (see also bladder) Phase II(Orphan Drug) Mississauga, Canada (905) 361-8686
Vectibix™ Amgen first-line therapy Phase IIIpanitumumab Thousand Oaks, CA (see also lung) (805) 447-1000
--------------------------------------------------------------------------------------second-line therapy Phase II
(805) 447-1000
XL-880 Exelixis (see also kidney, stomach) Phase IISouth San Francisco, CA (650) 837-7000GlaxoSmithKline (888) 825-5249Rsch. Triangle Park, NC
AMG 102 Amgen (see also brain, colorectal, Phase IIThousand Oaks, CA lung, stomach) (805) 447-1000
AMG 386 Amgen (see also breast, ovarian, Phase IIThousand Oaks, CA stomach, other) (805) 447-1000
Armala™ GlaxoSmithKline late-stage metastatic kidney cancer Phase IIIpazopanib Rsch. Triangle Park, NC (see also brain, breast, cervical, (888) 825-5249
liver, lung, ovarian, sarcoma, other)
AS-1411 Antisoma (see also leukemia) Phase II(Orphan Drug) Cambridge, MA (617) 225-0522
AV-951 AVEO Pharmaceuticals combination therapy Phase ICambridge, MA (see also lung, stomach) (617) 299-5000
Avastin® Genentech first-line metastatic renal cell carcinoma application submittedbevacizumab South San Francisco, CA (see also brain, colorectal, (650) 225-1000
IMC-1121B Eli Lilly metastatic kidney cancer Phase IIIndianapolis, IN (see also breast, colorectal, liver, (800) 545-5979ImClone Systems lung, ovarian, prostate, skin) (212) 645-1405New York, NY
IMO-2055 Idera Pharmaceuticals (see also colorectal, lung) Phase II completedCambridge, MA (617) 679-5500
ispinesib CytoKinetics (see also breast, colorectal, Phase IISouth San Francisco, CA leukemia) (650) 624-3000
KRX-0402 Keryx Biopharmaceuticals (see also brain, colorectal, Phase INew York, NY multiple myeloma, sarcoma) (212) 531-5965
LOR-2040 Lorus Therapeutics metastatic kidney cancer Phase II(Orphan Drug) Toronto, Canada (see also breast, colorectal, leukemia) (416) 798-1200
naptumomab Active Biotech (see also lung, pancreatic) Phase I completedestafenatox Lund, Sweden www.activebiotech.com
Oncophage® Antigenics (see also brain, colorectal, Phase IIvitespen New York, NY pancreatic, skin, stomach) (866) 805-8994
OncoVAX® Vaccinogen (see also colorectal, skin) Phase I/IIcancer vaccine Frederick, MD (301) 668-8400
ortataxel Spectrum Pharmaceuticals (see also lymphoma) Phase IIIrvine, CA (949) 788-6700
perifosine AEterna Zentaris (see also brain, head/neck, Phase IIMontreal, Canada lymphoma, multiple myeloma, (212) 531-5965Keryx Biopharmaceuticals ovarian, sarcoma)New York, NY
talactoferrin Agennix (see also lung) Phase II(Orphan Drug) Houston, TX (713) 552-1091
Torisel™ Wyeth Pharmaceuticals first-line therapy, late-stage kidney Phase IIItemsirolimus Collegeville, PA cancer (800) 934-5556(Orphan Drug) (see also colorectal, lung, lymphoma,
multiple myeloma, prostate)
tremelimumab Pfizer (see also breast, colorectal, lung, Phase INew York, NY prostate, skin) (860) 732-5156
TroVax® BioMedica Phase III(SAR109659) San Diego, CA (858) 677-6500
sanofi-aventis (800) 633-1610Bridgewater, NJ
Xcytrin® Pharmacyclics (see also brain, leukemia, lung, Phase IImotexafin Sunnyvale, CA lymphoma) (408) 774-0330gadolinium
XL-880 Exelixis (see also head/neck, stomach) Phase IISouth San Francisco, CA (650) 837-7000GlaxoSmithKline (888) 825-5249Rsch. Triangle Park, NC
Zolinza® Merck (see also brain, breast, colorectal, Phase I/IIvorinostat Whitehouse Station, NJ leukemia, lung, lymphoma, (800) 672-6372
multiple myeloma)
ZRx101 ZelleRx (see also multiple myeloma, skin, Phase IChicago, IL cancer-related) (312) 243-5200
ZYC300 Eisai (see also breast, colorectal, Phase IWoodcliff Lake, NJ ovarian, prostate) (888) 422-4743
L E U K E M I AProduct Name Sponsor Indication Development Status
ABT-263 Abbott Laboratories chronic lymphocytic leukemia (CLL) Phase I/IIAbbott Park, IL (see also lung, lymphoma) (847) 937-6100Genentech (650) 225-1000South San Francisco, CA
Ceplene™ EpiCept AML Phase III completedhistamine Tarrytown, NY (914) 606-3500dehydrochloride(Orphan Drug)
Clolar® Genzyme AML application submittedclofarabine Cambridge, MA (see also lymphoma) (617) 252-7500
--------------------------------------------------------------------------------------CLL, myelodysplastic syndromes Phase II
(617) 252-7500
CNF-2024 Biogen Idec CLL Phase ICambridge, MA (see also breast, solid tumors, (617) 679-2000
stomach)
CPX-351 Celator Pharmaceuticals AML Phase IIPrinceton, NJ (609) 243-0123
26 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
L E U K E M I AProduct Name Sponsor Indication Development Status
CYT-107 Cytheris myeloid leukemia Phase IRockville, MD (see also kidney, skin, solid tumors) (301) 231-0450
dacetuzumab Genentech CLL Phase I/II(anti-CD40) South San Francisco, CA (see also lymphoma, (650) 225-1000(Orphan Drug) Seattle Genetics multiple myeloma) (425) 527-4000
Bothell, WA
darinaparsin ZIOPHARM Oncology hematological malignancies Phase II(ZIO-101) New York, NY (see also liver, multiple myeloma, (646) 214-0700
solid tumors)
DCC-2036 Deciphera Pharmaceuticals ALL, CML Phase I/IILawrence, KS (785) 838-3767
Elacyt™ Clavis Pharma AML Phase IIelacytarabine Oslo, Norway (see also ovarian, skin) www.clavispharma.com(Orphan Drug)
Fodosine™ BioCryst Pharmaceuticals CLL, leukemia Phase IIforodesine Birmingham, AL (see also lymphoma) (205) 444-4600
GCS-100 Prospect Therapeutics CLL Phase IIWoburn, MA (see also lymphoma, (781) 939-5750
multiple myeloma)
Genasense® Genta CLL application submittedoblimersen Berkeley Heights, NJ (see also breast, lung, lymphoma, (908) 286-9800(Orphan Drug) skin, solid tumors)
--------------------------------------------------------------------------------------AML Phase III
(908) 286-9800
gimatecan Novartis Pharmaceuticals myelodysplastic syndromes Phase IEast Hanover, NJ (see also brain) (888) 669-6682
Gleevec® Novartis Pharmaceuticals AML Phase IIimatinib East Hanover, NJ (see also prostate) (888) 669-6682
GRN-163L Geron CLL Phase I/IIMenlo Park, CA (see also breast, lung, (650) 473-7700
multiple myeloma)
GRNVAC1 Argos Therapeutics AML Phase IIDurham, NC (see also prostate) (919) 287-6300Geron (650) 473-7700Menlo Park, CA
GS-9219 Gilead Sciences CLL Phase I/IIFoster City, CA (see also lymphoma) (800) 445-3235
27M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
L E U K E M I AProduct Name Sponsor Indication Development Status
INNO-305 CytRx AML, myelodysplastic syndromes Phase ILos Angeles, CA (see also solid tumors) (310) 826-5648
ISF35 Memgen CLL Phase IDallas, TX (214) 731-3141
ispinesib CytoKinetics hematological malignancies Phase ISouth San Francisco, CA (see also breast, colorectal, (650) 624-3000
kidney)
JNJ-26481585 Johnson & Johnson refractory metastatic leukemia, Phase IPharmaceutical Research refractory metastatic (800) 817-5286& Development myelodysplastic syndromesRaritan, NJ
JVRS-100 Juvaris BioTherapeutics Phase IBurlingame, CA (650) 259-1800
laromustine Vion Pharmaceuticals AML (first-line therapy in elderly application submitted(VNP 40101M) New Haven, CT patients) (203) 498-4210(Orphan Drug) (see also brain)
GC-33 Chugai Pharma USA Phase IBerkeley Heights, NJ (908) 516-1350
IMC-1121B Eli Lilly (see also breast, colorectal, kidney, Phase IIIndianapolis, IN lung, ovarian, prostate, skin) (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-A12 Eli Lilly (see also breast, colorectal, Phase IIIndianapolis, IN head/neck, lung, pancreatic, (800) 545-5979ImClone Systems prostate, sarcoma, solid tumors) (212) 645-1405New York, NY
irinotecan Biocompatibles metastatic liver cancer from Phase IIeluting beads International colorectal cancer www.biocompatibles.com
Surrey, United Kingdom
JX-594 Jennerex Biotherapeutics (see also solid tumors) Phase IISan Francisco, CA (415) 281-8886
mapatumumab Human Genome Sciences (see also lung, multiple myeloma) Phase I/IIRockville, MD (301) 309-8504
MB-7133 Metabasis Therapeutics inoperable, unresectable Phase I/II(Orphan Drug) La Jolla, CA liver cancer (858) 587-2770
melphalan drug Delcath Systems Phase IIIdelivery system New York, NY (212) 489-2100
NV1020 MediGene Phase I/IISan Diego, CA (858) 586-2240
patupilone Novartis Pharmaceuticals (see also brain, breast, colorectal, Phase II(EPO906) East Hanover, NJ lung, ovarian) (888) 669-6682
Tarceva® Genentech (see also bladder, brain, breast, Phase IIerlotinib South San Francisco, CA colorectal, head/neck, lung, other) (650) 224-1000
OSI Pharmaceuticals (800) 572-1932Melville, NY
Thermodox™ Celsion inoperable, unresectable liver cancer Phase IIILTSDEL Columbia, MD (see also breast) (410) 290-5390
Thymitaq® YM BioSciences (see also colorectal, head/neck, Phase IIInolatrexed Wayne, PA lung, pancreatic, prostate) (610) 560-0600(Orphan Drug)
TJ9 Tsumura Phase IITokyo, Japan www.tsumura.co.jp
L U N G C A N C E RProduct Name Sponsor Indication Development Status
1572932A GlaxoSmithKline non-small-cell lung cancer (NSCLC) Phase IIIRsch. Triangle Park, NC (888) 825-5249
Abraxane™ Abraxis BioScience NSCLC Phase IIIalbumin-bound Los Angeles, CA (see also head/neck, ovarian, (310) 883-1300paclitaxel pancreatic, prostate, skin)
ABT-263 Abbott Laboratories small-cell-lung cancer (SCLC) Phase I/IIAbbott Park, IL (see also leukemia, lymphoma) (847) 937-6100Genentech (650) 225-1000South San Francisco, CA
ABT-751 Abbott Laboratories NSCLC Phase IIAbbott Park, IL (see also breast, colorectal, kidney) (847) 937-6100
ABT-869 Abbott Laboratories NSCLC Phase IIAbbott Park, IL (see also breast, kidney, liver) (847) 937-6100Genentech (650) 225-1000South San Francisco, CA
Actimid™ Celgene SCLC (combination therapy) Phase I/IIpomalidomide Summit, NJ (see also multiple myeloma, (908) 673-9000
pancreatic, prostate, sarcoma)
Advexin® Introgen Therapeutics NSCLC (combination therapy) Phase IIcontusugene Austin, TX (see also bladder, brain, breast, (512) 708-9310ladenovec head/neck, ovarian, prostate,
stomach)--------------------------------------------------------------------------------------bronchioloalveolar adenocarcinoma Phase I
Eli Lilly first-line, second-line (800) 545-5979Indianapolis, IN (see also bladder, colorectal, (212) 645-1405ImClone Systems head/neck, prostate, stomach)New York, NY
eribulin mesylate Eisai NSCLC Phase II(E7389) Woodcliff Lake, NJ (see also breast, head/neck, ovarian, (888) 422-4743
prostate, sarcoma, solid tumors)
Gemzar® Eli Lilly metastatic SCLC Phase IIgemcitabine Indianapolis, IN (see also head/neck, lymphoma, (800) 545-5979
sarcoma)
Genasense® Genta NSCLC Phase II/IIIoblimersen Berkeley Heights, NJ (see also breast, leukemia, (908) 286-9800
lymphoma, skin, solid tumors)
GI-4000 GlobeImmune NSCLC Phase IILouisville, CO (see also pancreatic) (303) 625-2700
glufosfamide Threshold Pharmaceuticals SCLC Phase IIRedwood City, CA (see also breast, pancreatic, sarcoma) (650) 474-8200
GRN-163L Geron NSCLC (combination therapy) Phase IMenlo Park, CA (see also breast, leukemia, (650) 473-7700
multiple myeloma)
Hycamtin® GlaxoSmithKline NSCLC Phase IIItopotecan Rsch. Triangle Park, NC (see also breast, colorectal, (888) 825-5249
HyperAcute® Lung NewLink Genetics NSCLC Phase I/IIlung cancer Ames, IA (515) 296-5555vaccine
IMC-1121B Eli Lilly NSCLC Phase IIIndianapolis, IN (see also breast, colorectal, kidney, (800) 545-5979ImClone Systems liver, ovarian, prostate, skin) (212) 645-1405New York, NY
IMC-A12 Eli Lilly NSCLC (combination therapy) Phase IIIndianapolis, IN (see also breast, colorectal, (800) 545-5979ImClone Systems head/neck, liver, pancreatic, (212) 645-1405New York, NY prostate, sarcoma, solid tumors)
IMGN-901 ImmunoGen SCLC Phase IICambridge, MA (see also multiple myeloma) (617) 995-2500
IMO-2055 Idera Pharmaceuticals NSCLC (second-line therapy) Phase ICambridge, MA (see also colorectal, kidney) (617) 679-5500
INGN 225 Introgen Therapeutics SCLC Phase II(p53 vaccine) Austin, TX (see also breast) (512) 708-9310
38 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
L U N G C A N C E RProduct Name Sponsor Indication Development Status
Ixempra™ Bristol-Myers Squibb NSCLC in clinical trialsixabepilone Princeton, NJ (see also breast, pancreatic, prostate) (212) 546-4000
JNJ-26854165 Johnson & Johnson NSCLC Phase IPharmaceutical Research (see also prostate) (800) 817-5286& DevelopmentRaritan, NJ
Karenitecin® BioNumerik NSCLC (intravenous) Phase IIcositecan Pharmaceuticals (see also brain, ovarian, skin) (210) 614-1701
San Antonio, TX --------------------------------------------------------------------------------------NSCLC (oral) Phase I/II
(210) 614-1701
Levulan® PD DUSA Pharmaceuticals (see also bladder, cervical, in clinical trialsaminolevulinic acid Wilmington, MA colorectal, stomach) (978) 657-7500
Lucanix® NovaRx NSCLC Phase IIIbelagenpumatucel-L San Diego, CA (see also brain) (858) 552-8600
lung cancer AVAX Technologies NSCLC Phase I/IIvaccine Philadelphia, PA (215) 241-9760
lung cancer Pfizer NSCLC Phase Ivaccine New York, NY (860) 732-5156(NY-ESO-1)
mapatumumab Human Genome Sciences NSCLC Phase IIRockville, MD (see also liver, multiple myeloma) (301) 309-8504
milataxel Taxolog NSCLC Phase IIFairfield, NJ (see also breast, colorectal) (877) 829-6564
MK-0646 Merck NSCLC Phase I/IIWhitehouse Station, NJ (see also breast, pancreatic, other) (800) 672-6372
MKC 1 EntreMed NSCLC Phase IIRockville, MD (see also breast, leukemia, pancreatic) (240) 864-2600
MORAb-009 Eisai mesothelioma Phase IIWoodcliff Lake, NJ (see also ovarian, pancreatic) (888) 422-4743
--------------------------------------------------------------------------------------NSCLC Phase I
(888) 422-4743
motesanib Amgen NSCLC (combination therapy) Phase IIIThousand Oaks, CA (see also breast, colorectal, other) (805) 447-1000Millennium (800) 390-5663PharmaceuticalsCambridge, MA
naptumomab Active Biotech NSCLC Phase I completedestafenatox Lund, Sweden (see also kidney, pancreatic) www.activebiotech.com
neratinib Wyeth Pharmaceuticals NSCLC Phase II(HKI272) Collegeville, PA (see also breast) (800) 934-5556
39M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
L U N G C A N C E RProduct Name Sponsor Indication Development Status
Nexavar® Bayer HealthCare NSCLC (combination therapy) Phase IIIsorafenib Pharmaceuticals (see also breast, skin) (888) 842-2837
Wayne, NJ (510) 597-6500Onyx Pharmaceuticals --------------------------------------------------------------------------------------Emeryville, CA SCLC Phase II
non-Hodgkin’s lymphoma(see also leukemia, solid tumors)
milatuzumab Immunomedics non-Hodgkin’s lymphoma Phase I/II(IMMU-115) Morris Plains, NJ (see also leukemia, multiple (973) 605-8200
myeloma)
MLN8237 Millennium non-Hodgkin’s lymphoma Phase IIPharmaceuticals (see also brain, leukemia, (800) 390-5663Cambridge, MA solid tumors)
Nipent® Hospira cutaneous T-cell lymphoma application submittedpentostatin Lake Forest, IL (see also leukemia, cancer-related) (224) 212-2000(Orphan Drug) --------------------------------------------------------------------------------------
non-Hodgkin’s lymphoma Phase II(224) 212-2000
NPI-0052 Nereus Pharmaceuticals (see also multiple myeloma, Phase ISan Diego, CA solid tumors) (858) 587-4090
NPI-2358 Nereus Pharmaceuticals (see also lung) Phase ISan Diego, CA (858) 587-4090
(see also leukemia, lung)--------------------------------------------------------------------------------------mantle-cell lymphoma Phase I(combination therapy) (514) 281-8989
(see also leukemia)--------------------------------------------------------------------------------------non-Hodgkin’s lymphoma Phase II(first-line therapy), Waldenström’s (888) 825-5249macroglobulinemia
Oncaspar® Enzon Pharmaceuticals combination therapy Phase Ipegaspargase Bridgewater, NJ (see also solid tumors) (866) 792-5172
ortatexal Spectrum Pharmaceuticals non-Hodgkin’s lymphoma Phase IIIrvine, CA (see also kidney) (949) 788-6700
P276 Piramal Life Sciences mantle-cell lymphoma Phase IIMumbai, India (see also multiple myeloma)
panobinostat Novartis Pharmaceuticals cutaneous T-cell lymphoma Phase II/IIIEast Hanover, NJ (see also brain, breast, leukemia, (888) 669-6682
prostate)--------------------------------------------------------------------------------------Hodgkin’s disease Phase II
(888) 669-6682
PCI-32765 Pharmacyclics B-cell lymphoma Phase ISunnyvale, CA (408) 774-0330
47M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
L Y M P H O M AProduct Name Sponsor Indication Development Status
PD-332991 Pfizer mantle-cell lymphoma Phase INew York, NY (see also breast, multiple myeloma) (860) 732-5156
perifosine AEterna Zentaris Waldenström’s macroglobulinemia Phase IIMontreal, Canada (see also brain, head/neck, kidney, (212) 531-5965Keryx Biopharmaceuticals multiple myeloma, ovarian, New York, NY sarcoma)
pixantrone Cell Therapeutics non-Hodgkin’s lymphoma Phase IIISeattle, WA (800) 215-2355
PM-00104 PharmaMar USA (see also solid tumors) Phase ICambridge, MA (617) 868-3797
pralatrexate Allos Therapeutics B-cell lymphoma, Phase II(PDX) Westminster, CO peripheral T-cell lymphoma (303) 426-6262(Orphan Drug) (see also bladder, lung)
carfilzomib Proteolix monotherapy Phase II(Orphan Drug) South San Francisco, CA (see also leukemia, solid tumors) (650) 615-7550
--------------------------------------------------------------------------------------combination therapy Phase I
(650) 615-7550
CEP-18770 Cephalon Phase IFrazer, PA (610) 344-0200
CP-751871 Pfizer (see also breast, colorectal, lung, Phase I completedNew York, NY prostate, sarcoma) (860) 732-5156
CX-4945 Cylene Pharmaceuticals (see also solid tumors, other) Phase ISan Diego, CA (858) 875-5100
dacetuzumab Genentech (see also leukemia, lymphoma) Phase I(anti-CD40) South San Francisco, CA (650) 225-1000(Orphan Drug) Seattle Genetics (425) 527-4000
Bothell, WA
darinaparsin Ziopharm Oncology (see also leukemia, liver, Phase II(ZIO-101) New York, NY solid tumors) (646) 214-0700
denosumab Amgen (see also cancer-related, other) Phase III(AMG 162) Thousand Oaks, CA (805) 447-1000
50 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
M U L T I P L E M Y E L O M AProduct Name Sponsor Indication Development Status
elotuzumab Bristol-Myers Squibb Phase IPrinceton, NJ (212) 546-4000Facet Biotech (650) 454-1000Redwood City, CA
ENMD-2076 EntreMed (see also solid tumors) Phase IRockville, MD (240) 864-2600
enzastaurin Eli Lilly (see also brain, breast, colorectal, Phase II(LY317615) Indianapolis, IN lymphoma, ovarian, prostate) (800) 545-5979
GCS-100 Prospect Therapeutics (see also leukemia, lymphoma) Phase IWoburn, MA (781) 939-5750
GRN-163L Geron (see also breast, leukemia, lung) Phase IMenlo Park, CA (650) 473-7700
Hycamtin® GlaxoSmithKline (see also breast, colorectal, in clinical trialstopotecan Rsch. Triangle Park, NC head/neck, kidney, leukemia, lung, (888) 825-5249
Idamycin® Pfizer (see also lymphoma) Phase IIIidarubicin New York, NY (860) 732-5156
IMGN-901 ImmunoGen (see also lung) Phase ICambridge, MA (617) 995-2500
INCB-18424 Incyte (see also prostate) Phase IIWilmington, DE (302) 498-6700
IPH-2101 Innate Pharma Phase IMarseille, France www.innate-pharma.com
KRX-0402 Keryx Biopharmaceuticals (see also brain, colorectal, kidney, Phase IINew York, NY sarcoma) (212) 531-5965
lestaurtinib Cephalon (see also leukemia) Phase IIFrazer, PA (610) 344-0200
lucatumumab Novartis Pharmaceuticals (see also lymphoma) Phase IEast Hanover, NJ (888) 669-6682XOMA (510) 204-7200Berkeley, CA
LY2127399 Eli Lilly Phase IIIndianapolis, IN (800) 545-5979
mapatumumab Human Genome Sciences (see also liver, lung) Phase IIRockville, MD (301) 309-8504
milatuzumab Immunomedics (see also leukemia, lymphoma) Phase I/II(IMMU-115) Morris Plains, NJ (973) 605-8200
natalizumab Biogen Idec Phase I/IICambridge, MA (617) 679-2000
noscapine Cougar Biotechnology Phase I/IILos Angeles, CA (310) 943-8040
NPI-0052 Nereus Pharmaceuticals (see also lymphoma, solid tumors) Phase ISan Diego, CA (858) 587-4090
51M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
M U L T I P L E M Y E L O M AProduct Name Sponsor Indication Development Status
P276 Piramal Life Sciences (see also lymphoma) Phase IMumbai, India
PD-332991 Pfizer combination therapy Phase I/IINew York, NY (see also breast, lymphoma) (860) 732-5156
perifosine AEterna Zentaris (see also brain, head/neck, Phase IIMontreal, Canada kidney, lymphoma, ovarian, (212) 531-5965Keryx Biopharmaceuticals sarcoma)New York, NY
plitidepsin PharmaMar USA (see also lung, prostate) Phase II(Orphan Drug) Cambridge, MA (617) 868-3797
Quadramet® Cytogen (see also prostate, sarcoma, Phase I/IIsamarium sm-153 Princeton, NJ other) (800) 833-3533lexidronam injection
Revlimid® Celgene newly-diagnosed multiple myeloma Phase IIIlenalidomide Summit, NJ (see also leukemia, lymphoma, (908) 673-9000
prostate, other)
romidepsin Gloucester Pharmaceuticals (see also kidney, lymphoma, Phase IICambridge, MA pancreatic, prostate) (617) 583-1300
SF1126 Semafore Pharmaceuticals (see also solid tumors) Phase IIndianapolis, IN (317) 876-3075
tanespimycin Bristol-Myers Squibb (see also solid tumors) Phase III(Hsp90 inhibitor) Princeton, NJ (212) 546-4000
Torisel™ Wyeth Pharmaceuticals (see also colorectal, kidney, lung, Phase I/IItemsirolimus Collegeville, PA lymphoma, prostate) (800) 934-5556
Treanda® Cephalon Phase IIbendamustine Frazer, PA (610) 344-0200
Trisenox® Cephalon combination therapy Phase IIarsenic trioxide Frazer, PA (see also brain, leukemia) (610) 344-0200
VEL-0230 Velcura Therapeutics Phase I completedAnn Arbor, MI (734) 973-1000
Velcade® Millennium previously untreated multiple Phase IIIbortezomib Pharmaceuticals myeloma (800) 390-5663(subcutaneous) Cambridge, MA (see also lung, lymphoma, solid
tumors)
Zolinza® Merck (see also brain, breast, colorectal, Phase IIIvorinostat Whitehouse Station, NJ kidney, leukemia, lung, lymphoma) (800) 672-6372
ZRx101 ZelleRx (see also kidney, skin, Phase IChicago, IL cancer-related) (312) 243-5200
O VA R I A N C A N C E RProduct Name Sponsor Indication Development Status°A6 Angstrom Pharmaceuticals (see also other) Phase II
Solana Beach, CA (858) 314-2356
52 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O VA R I A N C A N C E RProduct Name Sponsor Indication Development Status
abagovomab Menarini Phase II/III(anti-idiotype Florence, Italy www.menarini.comovarian cancer vaccine)
Abraxane™ Abraxis BioScience (see also head/neck, lung, Phase IIalbumin-bound Los Angeles, CA pancreatic, prostate, skin) (310) 883-1300paclitaxel
Advexin® Introgen Therapeutics (see also bladder, brain, breast, Phase Icontusugene Austin, TX head/neck, lung, prostate, stomach) (512) 708-9310ladenovec
AE-37 Antigen Express combination therapy Phase IWorcester, MA (see also breast) (508) 852-8783
AG-14699 Pfizer (see also breast) Phase IINew York, NY (860) 732-5156
AGS-8M4 Agensys Phase ISanta Monica, CA (310) 820-8029Astellas Pharma US (800) 477-6472Deerfield, IL
Alimta® Eli Lilly (see also breast, head/neck, lung) Phase IIpemetrexed Indianapolis, IN (800) 545-5979
AMG 386 Amgen (see also breast, kidney, Phase IIThousand Oaks, CA stomach, other) (805) 447-1000
ANZ-207 Anza Therapeutics (see also lung, pancreatic) Phase IConcord, CA (925) 288-6000
Armala™ GlaxoSmithKline (see also brain, breast, cervical, Phase IIpazopanib Rsch. Triangle Park, NC kidney, liver, lung, sarcoma, other) (888) 825-5249
Avastin® Genentech (see also brain, colorectal, Phase IIIbevacizumab South San Francisco, CA head/neck, kidney, liver, lung, (650) 225-1000
AZD2281 AstraZeneca (see also breast) Phase IIWilmington, DE (800) 236-9933
AZD6244 AstraZeneca (see also leukemia, liver, lung, Phase IIWilmington, DE multiple myeloma, pancreatic, skin, (800) 236-9933
other)
belinostat TopoTarget USA (see also bladder, colorectal, leukemia, Phase IIRockaway, NJ liver, lung, lymphoma) (973) 895-6900
BMS-753493 Bristol-Myers Squibb in clinical trials(epothilone-folate) Princeton, NJ (212) 546-4000
BSI-201 BiPar Sciences combination and monotherapy Phase IIBrisbane, CA (see also brain, breast, other) (650) 635-6050
catumaxomab Fresenius Biotech (see also other) Phase IINorth America www.fresenius-biotech.comWaltham, MA
CDX-1307 Celldex Therapeutics (see also bladder, breast, colorectal, Phase INeedham, MA pancreatic) (781) 433-0771
53M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O VA R I A N C A N C E RProduct Name Sponsor Indication Development Status
D4064A Genentech (see also other) Phase ISouth San Francisco, CA (650) 224-1000
DCVax®-L Northwest Biotherapeutics Phase I/IIovarian cancer Bothell, WA (425) 608-3000vaccine
denenicokin ZymoGenetics (see also colorectal, kidney, Phase I/II(IL-21) Seattle, WA lymphoma, skin) (206) 442-6600
EC-145 Endocyte (see also lung, other) Phase IIWest Lafayette, IN (765) 463-7175
EGEN 001 Expression Genetics recurrent ovarian cancer Phase I(Orphan Drug) Huntsville, AL (combination therapy) (256) 512-0077
Elacyt™ Clavis Pharma (see also leukemia, skin) Phase IIelacytarabine Oslo, Norway www.clavispharma.com
enzastaurin Eli Lilly combination therapy Phase II(LY317615) Indianapolis, IN (see also brain, breast, colorectal, (800) 545-5979
lymphoma, multiple myeloma, prostate)
eribulin mesylate Eisai (see also breast, head/neck, lung, Phase II(E7389) Woodcliff Lake, NJ prostate, sarcoma, solid tumors) (888) 422-4743
farletuzumab Eisai Phase II/III(MORAb-003) Woodcliff Lake, NJ (888) 422-4743
Herceptin® Genentech (see also colorectal, pancreatic, Phase IItrastuzumab South San Francisco, CA prostate, stomach, other) (650) 225-1000
Hycamtin® GlaxoSmithKline (see also breast, colorectal, Phase IIItopotecan Rsch. Triangle Park, NC head/neck, kidney, leukemia, lung, (888) 825-5249(oral) lymphoma, multiple myeloma,
pancreatic, prostate, stomach, other)
iboctadekin GlaxoSmithKline combination therapy Phase IRsch. Triangle Park, NC (see also lymphoma) (888) 825-5249
idronoxil Marshall Edwards combination therapy Phase IIINorth Ryde, Australia (see also prostate, other)
IMC-1121B Eli Lilly (see also breast, colorectal, kidney, Phase IIIndianapolis, IN liver, lung, prostate, skin) (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMT-1012 ImmunoVaccine (see also breast) Phase ITechnologies (902) 492-1819Halifax, Canada
IT-101 Calando Pharmaceuticals (see also lymphoma) Phase IIPasadena, CA (626) 683-7200
Karenitecin® BioNumerik (see also brain, lung, skin) Phase IIIcositecan Pharmaceuticals (210) 614-1701
San Antonio, TX
lapuleucel-T Dendreon (see also breast, colorectal) Phase I completedSeattle, WA (206) 256-4545
54 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O VA R I A N C A N C E RProduct Name Sponsor Indication Development Status
Leukine® Bayer HealthCare (see also leukemia, lymphoma, Phase IIsargramostim Pharmaceuticals prostate, skin) (888) 842-2937
MORAb-009 Eisai (see also lung, pancreatic) Phase IWoodcliff Lake, NJ (888) 422-4743
NKTR-102 Nektar Therapeutics metastatic ovarian cancer Phase IISan Carlos, CA (second-line therapy) (650) 631-3100
(see also colorectal)
NOV-002 Novelos Therapeutics combination therapy Phase II completedNewton, MA (see also breast, lung) (617) 244-1616
oglufanide Implicit Bioscience Phase IIWoodside, CA (650) 851-3133
OGX-427 Oncogenex (see also bladder, breast, lung, Phase IPharmaceuticals prostate) (425) 686-1500Bothell, WA
Opaxio™ Cell Therapeutics (see also lung, stomach, other) Phase IIIpaclitaxel Seattle, WA (800) 215-2355poliglumex Novartis Pharmaceuticals (888) 669-6682
East Hanover, NJ
OvaRex® Paladin Labs Phase IIIoregovomab St. Laurent, Canada (514) 340-1112
OVax® AVAX Technologies Phase I/IIovarian cancer Philadelphia, PA (215) 241-9760vaccine(Orphan Drug)
patupilone Novartis Pharmaceuticals (see also brain, breast, colorectal, Phase III(EPO906) East Hanover, NJ liver, lung) (888) 669-6682
perifosine AEterna Zentaris (see also brain, head/neck, kidney, Phase IMontreal, Canada lymphoma, multiple myeloma, (212) 531-5965Keryx Biopharmaceuticals sarcoma)New York, NY
pertuzumab Genentech (see also breast) Phase II completedSouth San Francisco, CA (650) 225-1000
plevitrexed BTG International Phase II(BGC 9331) West Conshohocken, PA (610) 278-1660(Orphan Drug)
Quinamed® ChemGenex (see also breast, prostate) Phase IIamonafide Pharmaceuticals (650) 474-9800
Menlo Park, CA
sagopilone Bayer HealthCare combination therapy Phase I/IIPharmaceuticals (see also brain, breast, prostate) (888) 842-2937Wayne, NJ
SNS-595 Sunesis Pharmaceuticals (see also leukemia) Phase IISouth San Francisco, CA (650) 266-3500
55M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O VA R I A N C A N C E RProduct Name Sponsor Indication Development Status
systemic hedgehog Genentech (see also brain, colorectal, skin) Phase IIantagonist South San Francisco, CA (650) 224-1000
tasisulam (ASAP) Eli Lilly (see also leukemia, sarcoma, skin) Phase IIIndianapolis, IN (800) 545-5979
Telcyta™ Telik (see also breast, colorectal, lung) Phase IIIcanfosfimide Palo Alto, CA (650) 845-7700
topotecan Hana Biosciences (see also lung) Phase Iliposomal South San Francisco, CA (650) 588-6404
tucotuzumab EMD Serono (see also colorectal, lung, prostate) Phase IIcelmoleukin Rockland, MA (800) 283-8088
volociximab Biogen Idec (see also lung, pancreatic, skin) Phase IICambridge, MA (617) 679-2000Facet Biotech (650) 454-1000Redwood City, CA
Yondelis® Johnson & Johnson combination therapy, application submittedtrabectedin Pharmaceutical Research second-line therapy (800) 817-5286(Orphan Drug) & Development (see also breast, prostate, sarcoma,
Raritan, NJ other)
Zybrestat™ OXiGENE (see also head/neck, lung, other) Phase IIfosbretabulin Waltham, MA (781) 547-5900(Orphan Drug)
ZYC300 Eisai (see also breast, colorectal, kidney, Phase IWoodcliff Lake, NJ prostate) (888) 422-4743
P A N C R E A T I C C A N C E RProduct Name Sponsor Indication Development Status
Abraxane™ Abraxis BioScience (see also head/neck, lung, Phase I/IIalbumin-bound Los Angeles, CA ovarian, prostate, skin) (310) 883-1300paclitaxel
Actimid™ Celgene combination therapy Phase I/IIpomalidomide Summit, NJ (see also lung, multiple myeloma, (908) 673-9000
57M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
P A N C R E A T I C C A N C E RProduct Name Sponsor Indication Development Status
HyperAcute® NewLink Genetics Phase IIPancreas Ames, IA (515) 296-5555pancreatric cancer vaccine
IMC-A12 Eli Lilly first-line combination therapy Phase I/IIIndianapolis, IN (see also breast, colorectal, (800) 545-5979ImClone Systems head/neck, liver, lung, prostate, (212) 645-1405New York, NY sarcoma, solid tumors)
Ixempra™ Bristol-Myers Squibb (see also breast, lung, prostate) in clinical trialsixabepilone Princeton, NJ (212) 546-4000
larotaxel sanofi-aventis (see also bladder) Phase III(XRP9881) Bridgewater, NJ (800) 633-1610
masitinib AB Science USA (see also leukemia, stomach) Phase IIIShort Hills, NJ (973) 218-2437
MK-0646 Merck (see also breast, lung, other) Phase I/IIWhitehouse Station, NJ (888) 669-6682
MKC 1 EntreMed (see also breast, leukemia, lung) Phase IIRockville, MD (240) 864-2600
MORAb-009 Eisai (see also lung, ovarian) Phase IIWoodcliff Lake, NJ (888) 422-4743
naptumomab Active Biotech (see also kidney, lung) Phase I completedestafenatox Lund, Sweden www.activebiotech.com
OncoGel™ Protherics (see also brain, stomach) Phase IIBrentwood, TN (615) 327-1027
Oncophage® Antigenics (see also brain, colorectal, kidney, Phase I/IIvitespen New York, NY skin, stomach) (866) 805-8994
OncoVEX GM-CSF BioVex (see also skin) Phase IWoburn, MA (781) 376-4900
PancAtak™ Advantagene Phase Igene therapy Boston, MA (617) 916-5445
San Diego, CA (760) 943-8981
PN401 Wellstat Therapeutics (see also colorectal, stomach) Phase IIIGaithersburg, MD (240) 631-2500
PX-12 Oncothyreon (see also stomach, other) Phase IISeattle, WA (206) 801-2100
RAV-12 Raven Biotechnologies combination therapy Phase IISouth San Francisco, CA (see also other) (650) 624-2600
Rexin-G™ Epeius Biotechnologies recurrent, refractory metastatic Phase I/IItumor-targeted San Marino, CA pancreatic cancer (626) 441-6695gene therapy (see also breast, sarcoma)(Orphan Drug)
romidepsin Gloucester (see also kidney, lymphoma, Phase I/IIPharmaceuticals multiple myeloma, prostate) (617) 583-1300Cambridge, MA
RP-101 SciClone Pharmaceuticals Phase II(Orphan Drug) Foster City, CA (650) 358-3456
58 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
P A N C R E A T I C C A N C E RProduct Name Sponsor Indication Development Status
RTA-402 Reata Pharmaceuticals combination therapy Phase I/IIDallas, TX (see also leukemia) (972) 865-2200
salirasib Concordia Pharmaceuticals (see also lung) Phase I/II(Orphan Drug) Ft. Lauderdale, FL www.concordiapharma.com
Sarasar™ Schering-Plough (see also breast, leukemia) Phase IIlonafarnib Kenilworth, NJ (908) 298-4000
Sutent® Pfizer (see also breast, colorectal, liver, Phase IIIsunitinib New York, NY lung, prostate, sarcoma, stomach) (860) 732-5156
Thymitaq® YM BioSciences (see also colorectal, head/neck, Phase IInolatrexed Wayne, PA liver, lung, prostate) (610) 560-0600
deforolimus ARIAD Pharmaceuticals (see also breast, lung, sarcoma, Phase II(MK-8669) Cambridge, MA other) (617) 494-0400
Merck (800) 672-6372Whitehouse Station, NJ
DMXAA Antisoma (see also lung) Phase II completedCambridge, MA (617) 225-0522Novartis Pharmaceuticals (888) 669-6682East Hanover, NJ
enzastaurin Eli Lilly (see also brain, breast, colorectal, Phase II(LY317615) Indianapolis, IN lymphoma, multiple myeloma, (800) 545-5979
ovarian)
Erbitux® Bristol-Myers Squibb (see also bladder, colorectal, Phase IIIcetuximab Princeton, NJ head/neck, lung, stomach) (212) 546-4000
Eli Lilly (800) 545-5979Indianapolis, IN (212) 645-1405ImClone SystemsNew York, NY
eribulin mesylate Eisai hormone-refractory prostate cancer, Phase II(E7389) Woodcliff Lake, NJ prostate cancer (888) 422-4743
(see also breast, head/neck, lung, ovarian, sarcoma, solid tumors)
Gleevec® Novartis Pharmaceuticals (see also leukemia) Phase II/IIIimatinib East Hanover, NJ (888) 669-6682
GRNVAC1 Argos Therapeutics (see also leukemia) Phase I/IIDurham, NC (919) 287-6300Geron (650) 473-7700Menlo Park, CA
GTx-758 GTx Phase IMemphis, TN (901) 523-9700
HE-3235 Hollis-Eden late-stage prostate cancer Phase I/IIPharmaceuticals (858) 587-9333San Diego, CA
Herceptin® Genentech (see also colorectal, ovarian, Phase IItrastuzumab South San Francisco, CA pancreatic, stomach, other) (650) 225-1000
Hycamtin® GlaxoSmithKline (see also breast, colorectal, Phase IItopotecan Rsch. Triangle Park, NC head/neck, kidney, leukemia, lung, (888) 825-5249(oral) lymphoma, multiple myeloma,
ovarian, pancreatic, stomach, other)
61M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
P R O S T A T E C A N C E RProduct Name Sponsor Indication Development Status
HyperAcute® NewLink Genetics Phase I/IIProstate Ames, IA (515) 296-5555prostate cancer vaccine
idronoxil Marshall Edwards (see also ovarian, other) Phase IINorth Ryde, Australia
IMC-1121B Eli Lilly (see also breast, colorectal, kidney, Phase IIIndianapolis, IN liver, lung, ovarian, skin) (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-A12 Eli Lilly (see also breast, colorectal, Phase IIIndianapolis, IN head/neck, liver, lung, pancreatic, (800) 545-5979ImClone Systems sarcoma, solid tumors) (212) 645-1045New York, NY
INCB-18424 Incyte (see also multiple myeloma) Phase IIWilmington, DE (302) 498-6700
INSM-18 Insmed Phase I/II completedGlen Allen, VA (804) 565-3000
Ixempra™ Bristol-Myers Squibb (see also breast, lung, pancreatic) in clinical trialsixabepilone Princeton, NJ (212) 546-4000
JNJ-26854165 Johnson & Johnson (see also lung) Phase IPharmaceutical Research (800) 817-5286& DevelopmentRaritan, NJ
Leukine® Bayer HealthCare (see also leukemia, lymphoma, Phase IIsargramostim Pharmaceuticals ovarian, skin) (888) 842-2937
Wayne, NJ
Leupron Depot® Abbott Pharmaceuticals Phase IIIleuprorelin depot Abbott Park, IL (847) 937-6100(6-month formulation)
PSMA-ADC Progenics Pharmaceuticals Phase ITarrytown, NY (914) 789-2800
PSMA cancer Progenics Pharmaceuticals Phase Ivaccine Tarrytown, NY (914) 789-2800
Quadramet® Cytogen (see also multiple myeloma, Phase IIsamarium SM-153 Princeton, NJ sarcoma, other) (800) 833-3533lexidronam injection
Quinamed® ChemGenex (see also breast, ovarian) Phase IIamonafide Pharmaceuticals (650) 474-9800
Menlo Park, CA
Revlimid® Celgene (see also leukemia, lymphoma, Phase IIlenalidomide Summit, NJ multiple myeloma, other) (908) 673-4900
romidepsin Gloucester Pharmaceuticals (see also kidney, lymphoma, Phase II completedCambridge, MA multiple myeloma, pancreatic) (617) 583-1300
sagopilone Bayer HealthCare combination therapy Phase IIPharmaceuticals (see also brain, breast, ovarian) (888) 842-2937Wayne, NJ
satraplatin Spectrum hormone-refractory prostate cancer Phase IIIPharmaceuticals (combination therapy, (949) 788-6700Irvine, CA second-line therapy)
(see also breast, lung)
seocalcitol Cougar Biotechnology Phase I(CB1089) Los Angeles, CA (310) 943-8040
Sprycel™ Bristol-Myers Squibb (see also leukemia, solid tumors) in clinical trialsdasatinib Princeton, NJ (212) 546-4000
Sutent® Pfizer hormone-refractory metastatic Phase IIIsunitinib New York, NY prostate cancer (860) 732-5156
(see also breast, colorectal, liver, lung, pancreatic, sarcoma, stomach)--------------------------------------------------------------------------------------adjunctive treatment Phase II
(860) 732-5156
TAK683 Millennium Phase IPharmaceuticals (800) 390-5663Cambridge, MA
TAK700 Millennium Phase I/IIPharmaceuticals (800) 390-5663Cambridge, MA
tandutinib Millennium (see also brain) Phase II(MLN0518) Pharmaceuticals (800) 390-5663
Cambridge, MA
tesmilifene YM BioSciences (see also breast) Phase IIWayne, PA (610) 560-0600
64 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
P R O S T A T E C A N C E RProduct Name Sponsor Indication Development Status
TheraCIM™ YM Biosciences hormone-refractory prostate cancer Phase IInimotuzumab Wayne, PA (see also brain, breast, stomach) (610) 560-0600
Thymitaq® YM BioSciences (see also colorectal, head/neck, Phase IInolatrexed Wayne, PA liver, lung, pancreatic) (610) 560-0600
eribulin mesylate Eisai (see also breast, head/neck, lung, Phase II(E7389) Woodcliff Lake, NJ ovarian, prostate, solid tumors) (877) 873-4724
Fusilev™ Spectrum Pharmaceuticals (see also colorectal) application submittedlevoleucovorin Irvine, CA (949) 788-6700for injection
Gemzar® Eli Lilly (see also head/neck, lung, Phase IIgemcitabine Indianapolis, IN lymphoma) (800) 545-5979
glufosfamide Threshold Pharmaceuticals (see also breast, lung, pancreatic) Phase IIRedwood City, CA (650) 474-8200
IMC-A12 Eli Lilly soft tissue sarcoma Phase IIIndianapolis, IN (see also breast, colorectal, (800) 545-5979ImClone Systems head/neck, liver, lung, pancreatic, (212) 645-1405New York, NY prostate, solid tumors)
Junovan™ IDM Pharma osteosarcoma application submittedmifamurtide Irvine, CA (949) 470-4751
KRX-0402 Keryx Biopharmaceuticals (see also brain, colorectal, kidney, Phase IINew York, NY multiple myeloma) (212) 531-5965
palifosfamide ZIOPHARM Oncology combination therapy Phase II(ZIO-201) New York, NY (see also solid tumors) (212) 214-0700(Orphan Drug) --------------------------------------------------------------------------------------
monotherapy Phase I/II(212) 214-0700
66 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S A R C O M AProduct Name Sponsor Indication Development Status
perifosine AEterna Zentaris (see also brain, head/neck, Phase IIMontreal, Canada kidney, lymphoma, multiple (212) 531-5965Keryx Biopharmaceuticals myeloma, ovarian)New York, NY
Quadramet® Cytogen osteosarcoma Phase I/IIsamarium sm-153 Princeton, NJ (see also multiple myeloma, (800) 833-3533lexidronam prostate, other)injection
R1507 Roche (see also breast, lung, lymphoma) Phase IINutley, NJ (973) 235-5000
Reolysin® Oncolytics Biotech (see also brain, head/neck, lung, Phase IIreovirus Calgary, Canada skin) (403) 670-7377
Rexin-G™ Epeius Biotechnologies osteosarcoma Phase IItumor-targeted San Marino, CA (see also breast, pancreatic) (626) 441-6695gene therapy --------------------------------------------------------------------------------------
soft tissue sarcoma Phase I/II(626) 441-6695
robatumumab Schering-Plough osteosarcoma, sarcoma Phase IIKenilworth, NJ (see also colorectal) (908) 298-4000
Sutent® Pfizer soft tissue sarcoma Phase IIsunitinib New York, NY (see also breast, colorectal, liver, (860) 732-5156
lung, pancreatic, prostate, stomach)
tasisulam (ASAP) Eli Lilly soft tissue sarcoma Phase IIIndianapolis, IN (see also leukemia, ovarian, skin) (800) 545-5979
TH-302 Threshold soft tissue sarcoma Phase I/IIPharmaceuticals (see also solid tumors) (650) 474-8200Redwood City, CA
Yondelis® Johnson & Johnson first-line therapy Phase IIItrabectedin Pharmaceutical Research (see also breast, ovarian, prostate, (800) 817-5286(Orphan Drug) & Development other)
Raritan, NJ --------------------------------------------------------------------------------------in adolescents and children Phase II
(800) 817-5286
S K I N C A N C E RProduct Name Sponsor Indication Development Status
Abraxane™ Abraxis BioScience malignant melanoma Phase IIalbumin-bound Los Angeles, CA (see also head/neck, lung, ovarian, (310) 883-1300paclitaxel pancreatic, prostate)
ABT-888 Abbott Laboratories malignant melanoma Phase IIAbbott Park, IL (see also solid tumors) (847) 937-6100
67M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S K I N C A N C E RProduct Name Sponsor Indication Development Status
Allovectin-7® Vical metastatic melanoma Phase IIIvelimogene San Diego, CA (858) 646-1100aliplasmid(immunotherapeutic vaccine)(Orphan Drug)
ALS-357 Advanced Life Sciences malignant melanoma Phase I(betulinic topical) Woodridge, IL (630) 739-6744
Amplimexon® AmpliMed malignant melanoma Phase I/II completedimexon Tucson, AZ (see also breast, lung, multiple (520) 529-1000
myeloma, pancreatic, prostate)
ATN-224 Attenuon malignant melanoma Phase IISan Diego, CA (see also multiple myeloma, prostate) (858) 720-8797
AZD6244 AstraZeneca malignant melanoma Phase IIWilmington, DE (see also leukemia, liver, lung, (800) 236-9933
multiple myeloma, ovarian, pancreatic, other)
Azixa™ Myriad Pharmaceuticals malignant melanoma Phase I/II(MPC-6827) Salt Lake City, UT (see also brain) (801) 584-3600
IMC-1121B Eli Lilly metastatic malignant melanoma Phase IIIndianapolis, IN (see also breast, colorectal, kidney, (800) 545-5979ImClone Systems liver, lung, ovarian, prostate) (212) 645-1405New York, NY
INGN 241 Introgen Therapeutics malignant melanoma Phase II(mda-7) Austin, TX (see also head/neck) (512) 708-9310
interleukin-12 Inovio malignant melanoma Phase Igene therapy San Diego, CA (877) 446-6846
Karenitecin® BioNumerik malignant melanoma Phase II completedcositecan Pharmaceuticals (see also brain, lung, ovarian) (201) 614-1710
San Antonio, TX
Leukine® Bayer HealthCare malignant melanoma Phase IIsargramostim Pharmaceuticals (see also leukemia, lymphoma, (888) 842-2937
Wayne, NJ ovarian, prostate)
Lymphoseek™ Neoprobe diagnosis of malignant melanoma Phase IIIDublin, OH (see also breast) (800) 793-0079
Marqibo™ Hana Biosciences malignant melanoma Phase IIvincristine South San Francisco, CA (see also leukemia) (650) 588-6404liposomal(Orphan Drug)
Oncophage® Antigenics malignant melanoma Phase IIIvitespen New York, NY (see also brain, colorectal, kidney, (866) 805-8994
pancreatic, stomach)
OncoVAX® Vaccinogen malignant melanoma Phase I/IIcancer vaccine Frederick, MD (see also colorectal, kidney) (301) 668-8400
OncoVEX GM-CSF BioVex malignant melanoma Phase IIWoburn, MA (see also pancreatic) (781) 376-4900
PARP inhibitor Genentech malignant melanoma Phase ISouth San Francisco, CA (650) 225-1000
PEG-Intron A® Schering-Plough adjunctive treatment of stage III application submittedpeginterferon Kenilworth, NJ malignant melanoma (908) 298-4000alfa-2b (see also leukemia)
PEP-005 Peplin basal cell cancer Phase IIEmeryville, CA (510) 653-9700
PHP Curacyte malignant melanoma Phase IIChapel Hill, NC www.curacyte.com
PI-88 Progen Pharmaceuticals malignant melanoma Phase IIRedwood City, CA (650) 610-7080
Visudyne® QLT USA malignant melanoma Phase I/IIverteporfin Fort Collins, CO (800) 663-5486
volociximab Biogen Idec malignant melanoma Phase IICambridge, MA (see also lung, ovarian, pancreatic) (617) 679-2000Facet Biotech (650) 454-1000Redwood City, CA
Zadaxin® SciClone Pharmaceuticals malignant melanoma Phase IIthymalfasin Foster City, CA (650) 358-3456
ZRx101 ZelleRx malignant melanoma Phase IChicago, IL (see also kidney, multiple myeloma, (312) 243-5200
cancer-related)
S O L I D T U M O R SProduct Name Sponsor Indication Development Status
461364 GlaxoSmithKline (see also lymphoma) Phase IRsch. Triangle Park, NC (888) 825-5249
690693 GlaxoSmithKline (see also lymphoma) Phase IRsch. Triangle Park, NC (888) 825-5249
IMC-3G3 Eli Lilly Phase IIndianapolis, IN (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-18F1 Eli Lilly Phase IIndianapolis, IN (800) 545-5979ImClone Systems (212) 645-1405New York, NY
IMC-A12 Eli Lilly solid tumors in adolescents and Phase I/IIIndianapolis, IN children (800) 545-5979ImClone Systems (see also breast, colorectal, (212) 645-1405New York, NY head/neck, liver, lung, pancreatic,
STA-9090 Synta Pharmaceuticals (see also leukemia) Phase ILexington, MA (781) 274-8200
TAK593 Millennium Phase IPharmaceuticals (800) 390-5663Cambridge, MA
tanespimycin Bristol-Myers Squibb (see also multiple myeloma) Phase II(Hsp90 inhibitor) Princeton, NJ (212) 546-4000
Tarvacin™ Peregrine Pharmaceuticals Phase Ibavituximab Tustin, CA (714) 508-6000
TGF beta inhibitor Eli Lilly Phase IIndianapolis, IN (800) 545-5979
TH-302 Threshold combination therapy Phase I/IIPharmaceuticals (see also sarcoma) (650) 474-8200Redwood City, CA --------------------------------------------------------------------------------------
monotherapy Phase I(650) 474-8200
TLC388 Taiwan Liposome Phase ITaipei, Taiwan
TRC-093 TRACON Pharmaceuticals Phase ISan Diego, CA (858) 550-0780
tricirbine VioQuest Pharmaceuticals (see also leukemia) Phase I/II(VQD-002) Basking Ridge, NJ (908) 766-4400
IMGN-242 ImmunoGen gastric cancer Phase IICambridge, MA (see also solid tumors) (617) 995-2500
Levulan® PD DUSA Pharmaceuticals gastrointestinal cancer in clinical trialsaminolevulinic acid Wilmington, MA (see also bladder, cervical, (978) 657-7500
colorectal, lung)
masitinib AB Science USA GIST Phase IIIShort Hills, NJ (see also leukemia, pancreatic) (973) 218-2437
OncoGel™ Protherics esophageal cancer Phase IIBrentwood, TN (see also brain, pancreatic) (615) 327-1027
Oncophage® Antigenics (see also brain, colorectal, kidney, Phase I/IIvitespen New York, NY pancreatic, skin) (866) 805-8994
Opaxio™ Cell Therapeutics esophageal cancer, gastric cancer Phase Ipaclitaxel Seattle, WA (see also lung, ovarian, other) (800) 215-2355poliglumex Novartis Pharmaceuticals (888) 669-6682
East Hanover, NJ
PN401 Wellstat Therapeutics (see also colorectal, pancreatic) Phase IIGaithersburg, MD (240) 631-2500
PX-12 Oncothyreon gastrointestinal cancer Phase ISeattle, WA (see also pancreatic, other) (206) 801-2100
retaspimycin Infinity Pharmaceuticals GIST Phase III(IPI 504) Cambridge, MA (see also breast, lung) (617) 453-1000(Orphan Drug)
83M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S T O M A C H C A N C E RProduct Name Sponsor Indication Development Status
Sutent® Pfizer gastric cancer (combination therapy) Phase IIsunitinib New York, NY (see also breast, colorectal, liver, (860) 732-5156
lung, pancreatic, prostate, sarcoma)
TAS-102 Taiho Pharma USA gastric cancer Phase IIPrinceton, NJ (609) 750-5300
Tasigna® Novartis Pharmaceuticals GIST Phase IIInilotinib East Hanover, NJ (see also leukemia) (888) 669-6682(Orphan Drug)
tesetaxel Genta second-line therapy Phase II(Orphan Drug) Berkeley Heights, NJ (see also colorectal) (908) 286-9800
TheraCIM™ YM Biosciences esophageal cancer Phase IInimotuzumab Wayne, PA (neoadjuvant therapy) (610) 560-0600
(see also brain, breast, prostate)
TNFerade™ GenVec esophageal cancer Phase II completedGaithersburg, MD (see also colorectal, head/neck, (240) 632-0740
pancreatic, skin)
Tykerb® GlaxoSmithKline gastric cancer (combination therapy) Phase IIIlapatinib Rsch. Triangle Park, NC (see also brain, head/neck) (888) 825-5249
Xeloda® Roche esophageal cancer Phase IIcapecitabine Nutley, NJ (see also colorectal) (973) 235-5000
XL-880 Exelixis gastric cancer Phase IISouth San Francisco, CA (see also head/neck, kidney) (650) 837-7000GlaxoSmithKline (888) 825-5249Rsch. Triangle Park, NC
C A N C E R / C H E M O T H E R A P Y - R E L A T E D C O N D I T I O N SProduct Name Sponsor Indication Development Status
idronoxil Marshall Edwards fallopian tube cancer Phase I/IINorth Ryde, Australia (combination therapy)
(see also ovarian, prostate)
ING 1 Aduro BioTech adenocarcinoma Phase IBerkeley, CA (510) 848-4400
MCS110 Novartis Pharmaceuticals bone cancer Phase I/IIEast Hanover, NJ (see also prostate) (888) 669-6682
MER-101 Merrion Pharmaceuticals bone cancer Phase IIWilmington, NC (910) 799-1847
89M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O T H E R C A N C E R SProduct Name Sponsor Indication Development Status
MK-0646 Merck neuroendocrine tumors Phase IIWhitehouse Station, NJ (see also breast, lung, pancreatic) (888) 669-6682
MK-0822 Merck bone cancer Phase III completedWhitehouse Station, NJ (800) 672-6372
motesanib Amgen thyroid cancer Phase IIThousand Oaks, CA (see also breast, colorectal, lung) (805) 447-1000Millennium (800) 390-5663PharmaceuticalsCambridge, MA
NBI-42902 Neurocrine Biosciences uterine leiomyoma Phase ISan Diego, CA (see also breast, prostate) (858) 617-7600
Norprolac® Ferring Pharmaceuticals prolactinoma Phase IIquinagolide Suffern, NY www.ferring.com
Opaxio™ Cell Therapeutics peritoneal cancer Phase IIpaclitaxel Seattle, WA (see also lung, ovarian, stomach) (800) 215-2355poliglumex Novartis Pharmaceuticals (888) 669-6682
East Hanover, NJ --------------------------------------------------------------------------------------fallopian tube cancer Phase I/II
RAV-12 Raven Biotechnologies adenocarcinoma Phase I/IISouth San Francisco, CA (see also pancreatic) (650) 624-2600
relacatib GlaxoSmithKline cancer metastases Phase II(cathepsin Rsch. Triangle Park, NC (888) 825-5249K inhibitor)
Revlimid® Celgene central nervous system cancer Phase IIlenalidomide Summit, NJ (see also leukemia, lymphoma, (908) 673-9000
multiple myeloma, prostate)
saracatinib AstraZeneca metastatic bone cancer Phase IIWilmington, DE (800) 236-9933
seliciclib Cyclacel Pharmaceuticals nasopharyngeal cancer Phase IIShort Hills, NJ (see also lung) (973) 847-5955
Somatuline Tercica neuroendocrine tumors Phase IIIAutogel® Brisbane, CA (650) 624-4900lanreotide
90 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
O T H E R C A N C E R SProduct Name Sponsor Indication Development Status
Tarceva® Genentech gynecological cancer Phase IIerlotinib South San Francisco, CA (combination therapy) (650) 224-1000
OSI Pharmaceuticals (see also bladder, brain, breast, (800) 572-1932Melville, NY colorectal, head/neck, liver, lung)
Taxotere® sanofi-aventis pediatric cancer Phase IIIdocetaxel Bridgewater, NJ (800) 633-1610
V503 Merck vulvovaginal cancer prevention Phase IIIWhitehouse Station, NJ (see also cervical) (800) 672-6372
XL-184 Bristol-Myers Squibb medullary thyroid cancer Phase IIIPrinceton, NJ (see also brain) (212) 546-4000ExelixisSouth San Francisco, CA
Yondelis® Johnson & Johnson endometrial cancer Phase IItrabectedin Pharmaceutical Research (see also breast, ovarian, (800) 817-5286
& Development prostate, sarcoma)Raritan, NJ
Zactima® AstraZeneca medullary thyroid cancer Phase IIIvandetanib Wilmington, DE (see also brain, breast, lung) (800) 236-9933
Zybrestat™ OXiGENE thyroid cancer (combination therapy) Phase II/IIIfosbretabulin Waltham, MA (see also head/neck, lung, ovarian) (781) 547-5900(Orphan Drug)
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
1059615 GlaxoSmithKline Phase IRsch. Triangle Park, NC (888) 825-5249
1120212 GlaxoSmithKline Phase IRsch. Triangle Park, NC (888) 825-5249
AFX-9901 Afecta Pharmaceuticals in clinical trialsIrvine, CA (949) 253-4688
AG-24322 Pfizer Phase INew York, NY (860) 732-5156
AGS-16M18 Agensys Phase ISanta Monica, CA (310) 820-8029Astellas Pharma US (800) 477-6472Deerfield, IL
ALT-801 Altor BioScience Phase I/IIMiramar, FL (954) 443-8600
anti-HGF mAb Schering-Plough Phase IKenilworth, NJ (908) 298-4000
ANX-514 ADVENTRX Pharmaceuticals Phase I(docetaxel San Diego, CA (858) 552-0866emulsion)
91M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
ARRY-300 Array BioPharma Phase IBoulder, CO (303) 381-6600
ARRY-380 Array BioPharma Phase IBoulder, CO (303) 381-6600
ARRY-614 Array BioPharma Phase IBoulder, CO (303) 381-6600
AVR-118 Advanced Viral Research Phase IIYonkers, NY (914) 376-7383
belotecan ALZA Phase IMountain View, CA (650) 564-5000
BIO-109 Evolve Oncology Phase IINew York, NY (646) 723-8941
BIO-113 Evolve Oncology Phase IINew York, NY (646) 723-8941
BIO-121 Evolve Oncology Phase INew York, NY (646) 723-8941
BIO-128 Evolve Oncology Phase INew York, NY (646) 723-8941
Fibrovax™ Cytokine PharmaSciences Phase Icancer vaccine King of Prussia, PA (610) 687-1776
GPX-150 Gem Pharmaceuticals Phase I/IIBirmingham, AL (205) 982-0320
92 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
HuCAL fully Centocor Phase Ihuman antibody Horsham, PA (610) 651-6000
MorphoSysMartinsried, Germany
IAP antagonist Genentech Phase ISouth San Francisco, CA (650) 224-1000
IMC-18F1 ImClone Systems Phase INew York, NY (212) 645-1405
PCI-27483 Pharmacyclics Phase ISunnyvale, CA (408) 774-0330
93M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
PF-337210 Pfizer Phase INew York, NY (860) 732-5156
PF-562271 Pfizer Phase INew York, NY (860) 732-5156
PF-2341066 Pfizer Phase INew York, NY (860) 732-5156
PF-3084014 Pfizer Phase INew York, NY (860) 732-5156
PF-3446962 Pfizer Phase INew York, NY (860) 732-5156
PF-3732010 Pfizer Phase INew York, NY (860) 732-5156
PF-4217903 Pfizer Phase INew York, NY (860) 732-5156
PF-4554878 Pfizer Phase INew York, NY (860) 732-5156
PF-4856884 Pfizer Phase I(CovX060) New York, NY (860) 732-5156
PF-4929113 Pfizer Phase INew York, NY (860) 732-5156
PHA-848125 Nerviano Medical Sciences Phase INerviano, Italy www.nervianoms.com
QBI-139 Quintessence Biosciences Phase IMadison, WI (608) 441-2950
R306465 Johnson & Johnson Phase IPharmaceutical (800) 817-5286Research & DevelopmentRaritan, NJ
Rapamune® Wyeth Pharmaceuticals (see also cancer-related) Phase Isirolimus Collegeville, PA (800) 934-5556
RDEA-119 Ardea Biosciences Phase I/IISan Diego, CA (858) 652-6500
RDEA-436 Ardea Biosciences Phase 0San Diego, CA (858) 652-6500
SJG-136 Ipsen Phase IMilford, MA (508) 478-8900
SNX-5422 Serenex Phase IDurham, NC (919) 281-6001
SRT-501 Sirtris Pharmaceuticals Phase IICambridge, MA (617) 252-6920
94 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
TAK-285 Millennium Phase IPharmaceuticals (800) 390-5663Cambridge, MA
taltobulin Wyeth Pharmaceuticals Phase ICollegeville, PA (800) 934-5556
TRC-102 TRACON Pharmaceuticals Phase ISan Diego, CA (858) 550-0780
TRC-105 TRACON Pharmaceuticals Phase ISan Diego, CA (858) 550-0780
VTX-2337 VentiRx Pharmaceuticals Phase ISan Diego, CA (858) 436-1530
The content of this report has been obtained through industry sources and the Adis “R&D Insight” databasebased on the latest information. Report current as of March 23, 2009. The information may not be comprehensive.For more specific information about a particular product, contact the individual company directly or go towww.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site.
A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460
95M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
actinic keratoses—Roughness andthickening of the skin caused by over-exposure to the sun’s ultraviolet rays.It can degenerate into a skin cancercalled squamous cell carcinoma.
adenocarcinoma—Malignant tumorderived from a gland or glandulartissue.
adjunctive treatment—An auxiliarytreatment that is secondary to themain treatment.
adjuvant—A substance or drug thataids another substance in its action.
allogeneic—Refers to having celltypes that are distinct and causereactions in the immune system.
application submitted—An applica-tion for marketing has been submittedby the company to the Food andDrug Admin istra tion (FDA).
ascites—Excess fluid in the spacebetween the tissues lining theabdomen and abdominal organs (theperitoneal cavity).
basal cell cancer—Cancer of thelower layers of the skin.
B-cell—A class of white blood cellsimportant to the body’s immunesystem.
biliary—Relating to bile.
carcinoma—A malignant tumor thatarises from epithelial tissues, suchas skin.
cervical—Relating to the neck ofthe uterus.
chemoprotection—A therapeutictechnique in which bone marrowcells are removed from an individualwith cancer and are genetically mod-ified to withstand higher doses ofchemotherapy before being returnedto the donor.
cholangiocarcinoma—A malignancyof the biliary duct system that mayoriginate in the liver and extrahepaticbile ducts. More than 90 percent areadenocarcinomas, and the remainderare squamous cell tumors. Cholangio -carcinomas tend to grow slowly andto infiltrate the walls of the ducts. Eachyear, approximately 2,500 cases
occur, and the average incidence is1 case per 100,000 people per year.
cutaneous—Pertaining to the skin.
dysplasia—Abnormal tissue develop-ment.
gastric—Of or relating to the stomach.
GISTs—Gastrointestinal stromaltumors are uncommon tumors of theGI tract. Not all GISTs are cancerous;some are benign. Although thesecancers can arise anywhere in theGI tract, they occur most often inthe stomach (60% to 70%) and lesscommonly in the small intestine(20% to 30%). The rest are found inthe esophagus, large intestine, rectum,and anus. About 80% of people diag-nosed with GIST are older than 50.It is slightly more common in men.Blacks are more likely to developGISTs than whites.
glioblastoma—A fast growing andhighly malignant type of brain tumorarising from glial (supporting) cellswithin the brain. There are aboutfive to 10 new cases per millionpopulation per year in the UnitedStates, and the cause is unknown.
glioma—A type of brain tumor arisingfrom the supporting glial cells withinthe brain. Gliomas make up about60 percent of all primary brain tumorsand are frequently malignant.
graft-versus-host disease(GVHD)—A complication in bonemarrow transplants where immunesystem cells attack the transplantrecipient’s tissues.
head and neck cancer—The termgiven to a variety of malignant tumorsthat develop in the mouth, throat,paranasal sinuses, nasal cavity, larynx,and salivary glands. Many authori-ties also include skin tumors of theface and neck and tumors of the cer-vical lymph nodes. There are morethan half a million survivors of oral,head, and neck cancer living in theUnited States today.
hematological malignancies—Cancers of the blood or blood-forming tissues, such as leukemia,Hodgkin’s and non-Hodgkin’s lym-
hepatocellular cancer/carcinoma—A cancer that begins in the liver cells.
hyperuricemia—An abnormally highuric acid level in the blood.
imaging agent—A substance used toenhance x-ray images of organs andspaces in the body.
intraepithelial neoplasia, anal (AIN)& cervical (CIN)— AIN is a conse-quence of chronic human papillo-mavirus infection in the anal canaland appears to be driven by highviral loads of human papillomavirus.What is known of its natural historyresembles that of cervical intraep-ithelial neoplasia. Dysplasia and cer-vical intraepithelial neoplasia (CIN)are different terms or names for thesame condition—it is a precursor tocervical cancer. CIN may be mild,moderate or severe.
Kaposi’s sarcoma—A rare, malignantskin tumor that occurs in some AIDSpatients. It can be accompanied byfever, enlarged lymph nodes andgastro intestinal problems.
leiomyoma—A benign neoplasmderived from smooth muscle.
leukemia—A form of cancer in whichabnormally growing white blood cellsare scattered throughout the body andbone marrow. They can take over themarrow and prevent it from makingenough normal blood cells (white,red and platelets), leaving the patienthighly susceptible to serious infec-tions, anemia and bleeding episodes.The cells can also spill into the blood, infiltrating and interfering with thefunction of other organs. The fourmain types of leukemia are: acutelympho blastic leukemia (ALL), acute myeloid leukemia (AML), chroniclymphocytic leukemia (CLL), andchronic myeloid leukemia (CML).The acute types have a rapid onset,and overwhelming infection or bloodloss can cause death. The chronicforms progress much more slowly.
lung cancer—The leading cause of cancer deaths in both men and
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96 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
women. There are several types oflung cancer, the most common beingsquamous cell carcinoma, small (oat)cell carcinoma, adenocarcinoma andlarge cell carcinoma. Each has a dif-ferent growth pattern and response totreatment. The squamous cell, smallcell and large cell types are all stronglyassociated with tobacco abuse.
lymphoma—Cancers in which thecells of lymphoid tissue, found mainlyin the lymph nodes and spleen, mul-tiply unchecked. Lymphomas fall intotwo categories: Hodgkin disease,characterized by a particular kindof abnormal cell, and non-Hodgkinlymphomas, which vary in theirmalignancy according to the natureand activity of the abnormal cells.Mantle cell lymphoma is a type ofnon-Hodgkin lymphoma.
macroglobulinemia—A disorder inwhich plasma cells produce anexcessive quantity of macroglobulins(large antibodies) that accumulate inthe blood. It results from a group ofabnormal, cancerous lymphocytesand plasma cells. Men are affectedmore often than women, and theaverage age at onset is 65.
mastocytosis—A condition charac-terized by infiltration of mast cellsinto the tissues of the body. Mastcells are connective tissue cellswhich release chemicals includinghistamine that are very irritating andcause itching, swelling, and fluidleakage from cells.
medullary—Relating to the medulla(any soft marrow-like structure, espe-cially the innermost part) or marrow.
melanoma—A cancer made up of pigmented (usually brown-colored)skin cells anywhere in the body.
mesothelioma—A tumor of the lining ofthe lung and chest cavity (the pleura).
metastases/metastatic—Areas ofsecondary cancer that have spreadfrom the primary or original cancersite.
mucositis—The swelling, irritation,and ulceration of the mucosal cellsthat line the digestive tract. Mucositis
can occur anywhere along the diges-tive tract from the mouth to the anus.It can be a very troublesome andpainful side effect of chemotherapy.
multiple myeloma—A malignantcondition of middle to old age,characterized by the uncontrolledproliferation and dis ordered functionof plasma cells in the bone marrow.The condition, which makes thepatient particularly prone to infection,is rare, with about three new casesannually per 100,000 population.
myeloablation—A severe form ofmyelosuppression, a condition inwhich bone marrow activity isdecreased, resulting in fewer redblood cells, white blood cells, andplatelets. It is a side effect of somecancer treatments.
myelodysplastic syndromes (MDS)—Blood disorders that ultimately arefatal. Patients usually succumb to infections or bleeding. The term“preleukemia” has been used todescribe these disorders.
neoadjuvant therapy—Chemo -therapy, radiation therapy, or hor-mone therapy given before theprimary or main treatment. Neo -adjuvant therapy, like chemotherapyand radiation therapy, is often givenbefore surgery to reduce the size ofa tumor or to make surgery lesscomplicated.
neuroblastoma—A tumor of theadrenal glands or sympathetic nerv-ous system (the part of the nervoussystem responsible for certain auto-matic body functions, such as thecontrol of heart rate). Neuro blastomasare the most common extracranial(outside the skull) solid tumors ofchildhood.
osteosarcoma—Cancer of the bonethat occurs predominantly in adoles-cents and young adults. It accountsfor 5 percent of cancer in children
peritoneal—Relating to the peri-toneum, the membrane that lines theabdominal cavity and covers most ofthe abdominal organs.
Phase 0—First-in-human trials con-ducted in accordance with FDA’s2006 guidance on exploratoryInvestigational New Drug (IND) stud-ies designed to speed up developmentof promising drugs by establishingvery early on whether the agentbehaves in human subjects as wasanticipated from preclinical studies.
Phase I—Safety testing and pharma -cological profiling of new drugs insmall numbers of humans.
Phase II—Effectiveness testing andidentification of side effects of newdrugs in humans.
Phase III—Extensive clinical trialsin humans to verify effectiveness and monitor adverse reactions of new drugs.
prolactinoma—A noncancerouspituitary tumor that produces a hor-mone called prolactin, which resultsin too much prolactin in the blood.
refractory—Resistant to treatment orcure.
sarcoma—A malignant tumor thatarises from deep body tissues, suchas muscle, bone or fibrous tissue.
T-cell—One of two main classes ofwhite blood cells called lymphocytes,which are important to the body’sdisease-fighting immune system.
thrombocytopenia—A reduction inthe number of platelet cells in theblood, which causes a tendency tobleed, especially from the smallerblood vessels.
thymoma—Although rare, thymomasare the most common tumor of thethymus, a small organ located in theupper chest just below the neck thatproduces certain types of white bloodcells (lymphocytes) before birth andduring childhood. Thymomas arisefrom thymic epithelial cells, whichmake up the covering of the thymus.Up to 40 percent of thymomas areinvasive. They affect men and womenequally and are usually diagnosedbetween the ages of 40 and 60.Thymomas are uncommon in children.
unresectable—Unable to beremoved (resected) by surgery.
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97M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SOverview1
• In 2008, more than 1.4 million new cancer cases are expected to be diagnosed. The National Cancer Institute estimatesthat approximately 10.1 million Americans with a history of cancer were alive in January 2002. The 5-year relativesurvival rate for all cancers diagnosed between 1996 and 2003 is 66 percent, up from 50 percent in the mid-70s.
• Men have a little less than a 1 in 2 lifetime risk of developing cancer, and for women, the risk is a little more than1 in 3. About 77 percent of all cancers are diagnosed in people ages 55 and older.
• Scientific evidence suggests that about one-third of the cancer deaths expected this year will be related to overweightor obesity, physical inactivity, and nutrition, and thus could be prevented.
• Cancer is the second leading cause of death by disease—1 of every 4 deaths—in the United States, exceeded onlyby heart disease. This year, an estimated 565,650 are expected to die of cancer, more than 1,500 people a day.
Costs1
• The National Institutes of Health estimate overall costs for cancer in 2007 at $219.2 billion: $89 billion fordirect medical costs (total of all health expenditures); $18.2 billion for indirect morbidity costs (e.g., cost of lostproductivity due to illness); and $112 billion for indirect mortality costs (cost of lost productivity due topremature death).
Bladder (Urinary) Cancer1
• Nearly 69,000 new cases of bladder cancer are expected in 2008. The incidence rate is nearly four times higher inmen than in women and almost two times higher in whites than in African Americans.
• Bladder cancer will cause more than 14,000 deaths in 2008. Mortality rates have continued to decrease sincethe late ‘70s, although the rate of decrease slowed in the most recent time period (0.2 percent a year from1987-2004 compared with 2.1 percent a year from 1977-1987).
Breast Cancer1
• After continuously increasing for more than two decades, female breast cancer incidence rates decreased by 3.5percent per year from 2001-2004. From 1992-2004, incidence rates decreased among American Indians/AlaskaNatives (1.5 percent per year) and did not change significantly among Asian Americans/Pacific Islanders orHispanics/Latinas.
• Death rates from breast cancer have steadily decreased in women since 1990, with larger decreases in womenyounger than age 50 (a decrease of 3.3 percent per year) than in those age 50 and older (2 percent per year).From 1995-2004, female breast cancer death rates declined by 2.4 percent per year in whites and Hispanics/Latinas,1.6 percent per year in African Americans, and remained unchanged among Asian Americans/Pacific Islandersand American Indians/Alaska Natives. The decrease in breast cancer death rates represents progress in bothearlier detection and improved treatment.
Cervical Cancer/Uterine (Endometrial) Cancer1
• An estimated 11,070 cases of invasive cervical cancer are expected to be diagnosed in 2008. Incidence rates havedecreased steadily over the past several decades in both white and African-American women. Mortality rates havealso declined steadily; an estimated 3,870 cervical cancer deaths are expected in 2008.
• More than 40,000 cases of cancer of the uterine corpus (body of the uterus), usually of the endometrium or liningof the uterus, are expected to be diagnosed in 2008.
Colorectal Cancer1
• An estimated 108,070 colon and 40,740 rectal cancer cases are expected to occur in 2008. Colorectal cancer isthe third most common cancer in men and women. More than 90 percent of colorectal cancer cases are diagnosedin people over age 50.
98 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SColorectal Cancer1 (continued)
• Nearly 50,000 deaths from colorectal cancer are expected to occur this year, accounting for 9 percent of allcancer deaths. Mortality rates from colorectal cancer have declined in both men and women over the past twodecades with a steeper decline in the most recent time period (1.8 percent per year from 1985-2002 comparedto 4.7 percent from 2002-2004). That decrease reflects declining incidence rates and improvements in earlydetection and treatment.
Leukemia1
• An estimated 44,270 new leukemia cases are expected in 2008, with slightly more cases of chronic (19,940) thanacute (18,720) forms of the disease.
• Although often thought of as primarily a childhood disease, leukemia is diagnosed 10 times more often in adultsthan in children. Acute lymphocytic leukemia accounts for approximately 72 percent of the leukemia casesamong children. In adults, the most common types are acute myeloid leukemia (about 13,290 cases) andchronic lymphocytic leukemia (about 15,110 cases).
Lung Cancer1
• The estimated 215,020 new cases of lung cancer expected in 2008 will account for about 15 percent of cancerdiagnoses. The incidence rate is declining significantly in men, from a high of 102 cases per 100,000 in 1984 to73.6 in 2004. In women, the rate is approaching a plateau after a long period of increase.
• Lung cancer is the leading cause of cancer death in men and women. The estimated 161,840 deaths expectedthis year will account for about 29 percent of all cancer deaths. Death rates declined significantly in men from1991 to 2002 by about 1.9 percent per year. Since 1987, more women have died each year from lung cancerthan from breast cancer. Female lung cancer death rates are approaching a plateau after continuously increasingfor several decades, reflecting the decrease in smoking rates over the past 30 years.
Lymphoma1
• Of the estimated 74,340 new cases of lymphoma this year, 8,220 will be Hodgkin’s lymphoma and 66,120 will benon-Hodgkin’s lymphoma (NHL).
• Since the early 1970s, incidence rates for NHL have nearly doubled. Although some of this increase is due to AIDS-related NHL, for the most part, the rise is unexplained. Since 1991, increasing NHL incidence has been confined towomen.
• Over the past 30 years, incidence rates for Hodgkin’s lymphoma have decreased in men (0.7 percent per year)while they slightly increased in women (0.4 percent per year).
Ovarian Cancer1
• The estimated 21,650 new cases of ovarian cancer expected this year would account for about 3 percent of allcancers among women. It ranks second among gynecologic cancers, following cancer of the uterine corpus.
• Ovarian cancer causes more deaths than any other cancer of the female reproductive system—15,520 deaths areexpected in 2008.
Pain
• Most patients with cancer fear pain as their worst symptom. Indications are that 30 percent of those with newlydiagnosed cancer and 80 percent with previously diagnosed cancer have complaints of pain.2
• Studies have shown that 90 percent of patients with advanced cancer experience severe pain and that pain occursin 30 percent of all cancer patients, regardless of the stage of the disease. As many as 50 percent of patients maybe undertreated for cancer pain, yet not all cancer patients feel pain, and pain is rarely a sign of early cancer. Painusually increases as cancer progresses.3
99M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SPain (continued)
• The most common cancer pain is from tumors that metastasize to the bone—as many as 60 percent to 80 percent ofcancer patients with bone metastasis experience pain. The second most common cancer pain is caused by tumorsinfiltrating the nerve and hollow viscus. Tumors near neural structures may cause the most severe pain. The thirdmost common pain associated with cancer occurs as a result of chemotherapy, radiation, or surgery. Cancer painalso may occur in different parts of the body. In one study, more than 80 percent of patients experienced twodistinct pains, and more than 30 percent experienced three distinct pains.3
• Fewer than half of cancer patients who experience pain receive adequate treatment for their pain. More than half ofall hospitalized patients experienced pain in the last days of their lives, and although therapies are present toalleviate most pain for those dying of cancer, research shows that 50 percent to 75 percent of patients die inmoderate to severe pain.4
• African Americans and Hispanics are affected by racial profiling for diversion and under-treatment for pain by somephysicians. This is compounded by a lack of research on pain across racial and ethnic differences as well ascultural attitudes toward pain care. One study found that more than 80 percent of African-American patients and80 percent of Hispanic patients waited until their pain severity was a 10 on a 10-point scale before calling theirhealthcare provider or oncology clinic for assistance with pain management.4
• Chronic pain has been said to be the most costly health problem in America. Estimated annual costs, includingdirect medical expenses, lost income, lost productivity, compensation payments, and legal charges, are about$90 billion.5
Pancreatic Cancer1
• Nearly 38,000 new cases of pancreatic cancer are expected to occur in the United States in 2008. Incidence ratesof pancreatic cancer have been stable in men since 1993 and in women since 1983.
• More than 34,000 deaths from pancreatic cancer are expected this year. The death rate has continued to declinesince 1975 in men, while it has leveled off in women after increasing from 1975-1984.
Prostate Cancer1
• Prostate cancer is the most frequently diagnosed cancer in men—more than 186,000 new cases will be diagnosedin 2008. Incidence rates are significantly higher in African-American men than in white men. Rates peaked in whitemen in 1992 (237.8 per 100,000 men) and in African-American men in 1993 (343.1 per 100,000 men).
• Prostate cancer is a leading cause of cancer death in men, and an estimated 28,660 are expected to die thisyear. Although death rates have decreased more rapidly among African-American men than among white mensince the early 1990s, rates in African-American men still remain more than twice as high as those in white men.
Skin Cancer1
• The most serious form of skin cancer is melanoma, which is expected to be diagnosed in more than 62,000 peoplein 2008. During the 1970s, the incidence rate for melanoma increased rapidly by about 6 percent annually. From1981-2000, the rate of increase slowed to 3 percent per year, and since 2000, melanoma incidence has beenstable. Melanoma is primarily a disease of whites—rates are more than 10 times higher in whites than in AfricanAmericans.
• Skin cancer will cause more than 11,000 deaths in 2008—8,420 from melanoma and 2,780 from othernonepithelial skin cancers. The death rate for melanoma has been decreasing rapidly in whites younger than age50, by 3 percent a year since 1991 in men and by 2.3 percent a year since 1985 in women. In those older thanage 50, rates have been stable since 1998 in men and since 1990 in women.
100 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SNew Cancer Cases/Deaths 1
Cancer Type Estimated 2008 New Cases Estimated 2008 Deaths
All Sites 1,437,180 565,650
Male 745,180 294,120
Female 692,000 271,530
Acute Lymphocytic Leukemia 5,430 1,460
Male 3,220 800
Female 2,210 660
Acute Myeloid Leukemia 13,290 8,820
Male 7,200 5,100
Female 6,090 3,720
Bladder Cancer 68,810 14,100
Male 51,230 9,950
Female 17,580 4,150
Bone Cancer (and joints) 2,380 1,470
Male 1,270 820
Female 1,110 650
Brain Cancer (and other nervous system) 21,810 13,070
Male 11,780 7,420
Female 10,030 5,650
Breast Cancer 184,450 40,930
Male 1,990 450
Female 182,460 40,480
Cervical Cancer/Uterine Cancer 51,170 11,340
Male — —
Female 51,170 11,340
Chronic Lymphocytic Leukemia 15,110 4,390
Male 8,750 2,600
Female 6,360 1,790
Chronic Myeloid Leukemia 4,830 450
Male 2,800 200
Female 2,030 250
Colorectal Cancer 148,810 49,960
Male 77,250 24,260
Female 71,560 25,700
Esophageal Cancer 16,470 14,280
Male 12,970 11,250
Female 3,500 3,030
101M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SNew Cancer Cases/Deaths 1 (continued)
Cancer Type Estimated 2008 New Cases Estimated 2008 Deaths
Kidney Cancer (and renal pelvis) 54,390 13,010
Male 33,130 8,100
Female 21,260 4,910
Leukemia (all types) 44,270 21,710
Male 25,180 12,460
Female 19,090 9,250
Liver Cancer 21,370 18,410
Male 15,190 12,570
Female 6,180 5,840
Lung Cancer (and bronchus) 215,020 161,840
Male 114,690 90,810
Female 100,330 71,030
Lymphoma (all types) 74,340 20,510
Male 39,850 10,490
Female 34,490 10,020
Lymphoma (non-Hodgkin’s) 66,120 19,160
Male 35,450 9,790
Female 30,670 9,370
Melanoma-Skin Cancer 62,480 8,420
Male 34,950 5,400
Female 27,530 3,020
Multiple Myeloma 19,920 10,690
Male 11,190 5,640
Female 8,730 5,050
Ovarian Cancer 21,650 15,520
Male — —
Female 21,650 15,520
Pancreatic Cancer 37,680 34,290
Male 18,770 17,500
Female 18,910 16,790
Prostate Cancer 186,320 28,660
Male 186,320 28,660
Female — —
Stomach Cancer 21,500 10,880
Male 13,190 6,450
Female 8,310 4,430
102 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SSources:
1. Cancer Facts & Figures 2008, American Cancer Society (www.cancer.org)
2. Journal of the American Osteopathic Association (www.jaoa.org)
3. Oncology Channel® (www.oncologychannel.com)
4. American Pain Foundation (www. painfoundation.org)
5. Oregon Health and Science University (www.ohsu.edu)
103M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2009
T H E D R U G D I S C O V E R Y , D E V E L O P M E N T A N D A P P R O V A L P R O C E S S
It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
The U.S. system of new drug approvals is perhapsthe most rigorous in the world.
It takes 10-15 years, on average, for an experimentaldrug to travel from lab to U.S. patients, according tothe Tufts Center for the Study of Drug Development,based on drugs approved from 1994 through 1998.Only five in 5,000 compounds that enter preclinicaltesting make it to human testing. And only one of thosefive is approved for sale.On average, it costs a company $1.3 billion to get
one new medicine from the laboratory to U.S. patients,according to a 2007 study by the Tufts Center for theStudy of Drug Development.Once a new compound has been identified in the
laboratory, medicines are developed as follows:Preclinical Testing. A pharmaceutical company con -
ducts laboratory and animal studies to show biologicalactivity of the compound against the targeted disease,and the compound is evaluated for safety.Investigational New Drug Application (IND). After
completing preclinical testing, a company files an INDwith the U.S. Food and Drug Administration (FDA) tobegin to test the drug in people. The IND becomeseffective if FDA does not disapprove it within 30 days.The IND shows results of previous experiments; how,where and by whom the new studies will be conducted;the chemical structure of the compound; how it isthought to work in the body; any toxic effects foundin the animal studies; and how the compound is man -ufactured. All clinical trials must be reviewed andapproved by the Institutional Review Board (IRB)where the trials will be conducted. Progress reportson clinical trials must be submitted at least annuallyto FDA and the IRB.
Clinical Trials, Phase I. These tests involve about 20to 100 normal, healthy volunteers. The tests study adrug’s safety profile, including the safe dosage range.The studies also determine how a drug is absorbed,distributed, metabolized, and excreted as well as theduration of its action. Clinical Trials, Phase II. In this phase, controlled
trials of approximately 100 to 500 volunteer patients(people with the disease) assess a drug’s effectiveness.Clinical Trials, Phase III. This phase usually involves
1,000 to 5,000 patients in clinics and hospitals.Physicians monitor patients closely to confirm efficacyand identify adverse events. New Drug Application (NDA)/Biologic License
Application (BLA). Following the completion of allthree phases of clinical trials, a company analyzes allof the data and files an NDA or BLA with FDA if thedata successfully demonstrate both safety and effec -tiveness. The applications contain all of the scientificinformation that the company has gathered.Applications typically run 100,000 pages or more.The average review time for the 24 new therapeuticsapproved by the FDA in 2008 was 17.8 months.Approval. Once FDA approves an NDA or BLA, the
new medicine becomes available for physicians toprescribe. A company must continue to submit periodicreports to FDA, including any cases of adverse reactionsand appropriate quality-control records. For somemedicines, FDA requires additional trials (Phase IV) toevaluate long-term effects. Discovering and developing safe and effective new
medicines is a long, difficult, and expensive process.Pharmaceutical companies invested an estimated$65.2 billion in research and development in 2008.
Clinical Trials
Discovery/ Phase Phase Phase PhasePreclinical Testing I II III FDA IV
Years
TestPopulation
Purpose
SuccessRate
6.5
Laboratory andanimal studies
Assess safety,biologicalactivity andformulations
5,000compounds evaluated
1.5
20 to 100healthy
volunteers
Determinesafetyand
dosage
2
100 to 500patient
volunteers
Evaluateeffectiveness,
look forside effects
1.5
Reviewprocess/approval
1approved
Additionalpost-
marketingtestingrequiredby FDA
3.5
1,000 to 5,000patient
volunteers
Confirm effectiveness,monitor adverse reactions from long-term use
5enter trials
File IN
D at FDA
File NDA/BLA at FDA
T H E D R U G D E V E L O P M E N T A N D A P P R O V A L P R O C E S S
New Medicines. New Hope.®
Pharmaceutical Research and Manufacturers of America
Medicines in Development for Cancer is presented by PhRMA in cooperation with the following organizations:
Being listed in this report in no way implies that the above-mentioned organizations endorse or recommendthe use of any of the products in development contained in this publication. For further information, patientsshould consult their physicians or health care providers.
American Brain Tumor AssociationAmerican Nurses AssociationAssociation of Community Cancer CentersBurger King Cancer Caring CenterChemotherapy FoundationOncology Nursing SocietyPAACT (Patient Advocates for Advanced