Company recalls application for hormone-refractory PCa drug
GPC Biotech AG has retracted its new drug application for satraplatin, which was submitted for rapid approval to treat hormone-refractory prostate cancer patients who had experienced unsuccessful previous chemotherapy.
GPC Biotech AG has retracted its new drug application for satraplatin, which was submitted for rapid approval to treat hormone-refractory prostate cancer patients who had experienced unsuccessful previous chemotherapy.
The withdrawal was the result of a vote on July 24, 2007, by the Oncologic Drugs Advisory Committee to FDA that stated FDA should hold off on approval until the final survival analysis of a satraplatin trial known as SPARC was completed. SPARC trial results are expected within 5 months.
If the overall survival data from the SPARC trial are positive, GPC Biotech said it would submit a new drug application to the FDA "as quickly as possible."
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