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WASHINGTON (AP) -- Government medical advisers on Tuesday told the Food and Drug Administration to wait for more data about GPC Biotech's prostate cancer-fighting drug Orplatna before making a decision about its safety and effectiveness.
The 12 members of the agency's cancer drug panel voted unanimously to delay a decision on the experimental cancer treatment until the company submits final data on patient survival times, according to FDA spokeswoman Karen Riley.
FDA is not required to follow the experts' advice, though it usually does.
Company representatives said they would not be able to deliver the requested data until late 2008, according to Riley. Previously the company estimated it could have the data by later this year.
The panel vote Tuesday squares with FDA's review of the drug released ahead of the meeting, in which agency staffers voiced several complaints with the Munich, Germany-based company's application.
FDA staffers said they were unfamiliar with the statistical methods the company used to measure the effectiveness of the drug. GPC used a so-called composite endpoint, which combines data on pain, weight loss and other effects of prostate cancer.
"The FDA has no prior experience with this endpoint," FDA wrote. "This was clearly communicated to the applicant during the development phase."
FDA also said two of its reviewers disagreed on the progress made by 39 percent of patients in the study, raising the question of whether the main goal of the study could be reliably assessed.
Shares of Munich, Germany-based GPC Biotech AG fell 59 cents, or 2.8 percent, Tuesday to $20.36. The company halted trading in the early afternoon pending news from FDA panel.
FDA Panel Votes for Delay on GPC Drug
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