ODAC recommends that FDA wait for overall survival results.
An FDA advisory panel recommended that the agency hold off on sanctioning GPC Biotech’s prostate cancer drug until receipt of final survival data from an ongoing trial. The company lost over 52% of its value to open trading today at $13.35. Spectrum Pharmaceuticals, one of the company’s licensing partners, also saw an almost 15% drop in its stock price.
Satraplatin is under priority review for the treatment of hormone-refractory prostate cancer in patients whose prior chemotherapy has failed. The company expects to receive a final decision from FDA in August.
Although GPC Biotech has reported decreases in the relative risk of disease progression due to Satraplatin, the Oncologic Drugs Advisory Committee (ODAC) reportedly said that the company doesn’t prove the drug helps prostate cancer patients live longer.
GPC Biotech says that due to a recent slowing in the reported rate of deaths in the SPARC trial, final overall survival results could take longer than the previously communicated timeframe of the fall of this year.
“While we are extremely disappointed that ODAC has recommended that the FDA wait for the results of the overall survival analysis, we will continue to work with the FDA as the agency continues its review of the satraplatin application,” says Bernd R. Seizinger, M.D., Ph.D., CEO of GPC Biotech.
