FDA Approves Eli Lilly's Gemzar To Treat Ovarian Cancer; Contraceptive Implanon Also Approved

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 20 Jul 2006 - 9:00 PDT

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FDA has approved Eli Lilly's drug Gemzar for use in combination with FDA-approved carboplatin -- a chemotherapy drug -- for treatment of advanced, recurrent ovarian cancer, the company announced Monday, Reuters reports. The approval comes despite the recommendation earlier this year of an FDA panel to reject the approval (Pierson, Reuters, 7/17). The panel in March voted 9-2 to recommend the agency reject an application to market the drug. The agency in 1996 had 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 (Kaiser Daily Women's Health Policy Report, 3/14). Lilly spokesperson Gregory Clarke said the agency approved Gemzar for ovarian cancer because the company filed additional information that highlighted the benefits of the drug. Gemzar does not increase survival time, but it increases the time women can go without treatment, thereby freeing them from the side effects of chemotherapy, Clarke said. He added that the approval marked the first time FDA has approved an ovarian cancer drug because it helps women to prolong periods between treatments, rather than for its survival benefit (Reuters, 7/17). Lilly said it is testing other treatments for ovarian cancer (Dow Jones, 7/17).

FDA Approves Implanon
In related news, FDA has approved Dutch pharmaceutical company Akzo Nobel's contraceptive implant Implanon, the company announced Tuesday (AFX/Forbes, 7/18). Implanon, a one-inch plastic rod inserted by a doctor into a woman's upper arm, releases progesterone, inhibiting pregnancy for up to three years or until the device is surgically removed. FDA in November 2004 granted approval status to the contraceptive (Kaiser Daily Women's Health Policy Report, 11/4/04). Akzo Nobel's human health care division Organon USA later this year plans to train health care providers on how to insert and remove the device, so that the use of Implanon can be expanded in 2007 (Akzo Nobel release, 7/18).

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