Advisory Committee Recommends FDA Wait for Satraplatin Survival Results
GPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US 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 satraplatin is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.
GPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US 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 satraplatin is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.
As a result, GPC Biotech has withdrawn its New Drug Application for accelerated approval of the drug. The company anticipates overall survival results to be available within 6 months.
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