FDA Committee: Wait for HRPC Trial Results

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The FDA's Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended that the agency wait for the final survival analysis of a phase III trial before deciding if satraplatin is approvable for the treatment of hormone-refractory prostate cancer (HRPC) patients whose prior chemotherapy has failed.

 

“While we are 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 it continues its review of the satraplatin application,” said Bernd R. Seizinger, MD, PhD, chief executive officer of GPC Biotech AG of Munich, Germany, which makes the drug. Satraplatin is a platinum-based oral compound that trial patients are able to take at home.

 

All platinum drugs currently on the market require IV administration. The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with HRPC.

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