Global Processing

FDA says Lilly drug doesn’t help ovarian cancer

March 13, 2006

Eli Lilly & Co.''s cancer drug Gemzar used in combination with a chemotherapy agent did not appear to adequately improve survival and increased toxicity for patients with advanced ovarian cancer, U.S. regulatory staff said. Reuters reports that the Food and Drug Administration staff report was released ahead of a FDA advisory meeting of outside experts to discuss whether to approve wider use of the drug. The injectable drug is already approved to treat lung, pancreatic and breast cancers. Lilly is now seeking U.S. approval to market Gemzar to treat ovarian cancer when used with the chemotherapy drug carboplatin. In their report, agency staff said the drug combination extended time without disease progression for 2.8 months but it was not clear if the extra time was worthwhile. FDA officials will make the final decision, but usually follow the advice of the agency''s advisory panels. The drug was approved for ovarian cancer in several European countries in 2004.