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As a result, GPC Biotech has withdrawn its New Drug Application for accelerated approval of the drug.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.
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
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