US panel: FDA needs more data on GPC cancer drug

(Adds panel member, company comments)

By Lisa Richwine

ROCKVILLE, Md., July 24 (Reuters) - U.S. regulators should wait for more data before deciding whether to approve GPC Biotech AG's (GPCG.DE: Quote, Profile, Research, Stock Buzz) proposed prostate cancer pill Orplatna, an advisory panel said on Tuesday in a 12-0 vote.

The committee said it was important to see if patients who took Orplatna in a company trial lived longer than others who got a placebo. GPC officials said it could take another year for that information to be available.

"Survival benefit may well be seen, but I don't think we see it at the current time," said Dr. Wyndham Wilson, a panel member and National Cancer Institute researcher.

An interim analysis as of June 15, 2006, showed survival was no better with Orplatna than a placebo, U.S. Food and Drug Administration staff said.

Orplatna, known generically as satraplatin, is the lead product candidate for Germany-based GPC Biotech.

Spectrum Pharmaceuticals Inc. (SPPI.O: Quote, Profile, Research, Stock Buzz), which licensed the drug to GPC, has the option to co-promote Orplatna in the United States. Pharmion Corp. PHRM.O owns rights to sell the drug in Europe and some other territories.

The FDA usually follows recommendations from its panels of outside experts. The agency is expected to decide whether to clear Orplatna based on current data by Aug. 15.