FDA Panel Recommends Rejection Of Eli Lilly Drug Gemzar To Treat Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Mar 2006 - 0:00 PDT

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An FDA panel on Monday voted 9-2 to recommend the agency reject an application by Eli Lilly to market the drug Gemzar, in combination with FDA-approved carboplatin, as a treatment for advanced ovarian cancer, Dow Jones/Wall Street Journal reports. FDA in 1996 approved Gemzar, which is considered a chemotherapy drug, to treat pancreatic cancer, and since then it has been approved as a treatment for lung and breast cancers. FDA's Oncologic Drugs Advisory Committee found that data provided by Lilly on the use of Gemzar, known generically as gemcitabine, for advanced ovarian cancer were not strong enough to merit approval. In a study Lilly submitted to the panel, findings show that while a combination of Gemzar and carboplatin increased median progression-free survival -- which means that the cancer was not growing -- in patients by 2.8 months when compared with carboplatin alone, there was no difference in the overall length of patients' survival. FDA also said that patients taking Gemzar experienced additional side effects, such as anemia and other blood problems. "The main issue is whether adding 2.8 months to median progression-free survival at a cost of additional toxicity with no apparent effect on survival is a sufficient basis for Gemzar approval for this use," FDA said (Corbett Dooren, Dow Jones/Wall Street Journal, 3/13). Garry Nicholson, executive director of oncology drug development for Lilly, said the company is "really disappointed" with the panel's decision (Indianapolis Star, 3/14). FDA, which typically follows its panels' advice, is expected to decide on the application by the end of April. If the application is rejected, doctors could continue to prescribe Gemzar for off-label use as a treatment for ovarian cancer, Dow Jones/Journal reports (Dow Jones/Wall Street Journal, 3/13).

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