GPC Biotech AG has announced that the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.
The FDA is not bound by the recommendations of advisory committees but will consider their advice when reviewing an applicant's NDA.
The Company said 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," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. "We continue to believe strongly in the potential for satraplatin to help hormone-refractory prostate cancer patients who today have very limited treatment options."
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority, and no conclusions can or should be drawn regarding its safety and efficacy.