GPC pulls Orplatna NDA
This article was originally published in Pharmaceutical Approvals Monthly
GPC Biotech will resubmit an NDA for Orplatna (satraplatin) for treatment of hormone-refractory prostate cancer after overall survival data from an ongoing trial become available, likely next year, the Princeton, N.J. company announces July 30. The decision to withdraw the application follows a July 24 Oncologic Drugs Advisory Committee recommendation that FDA await overall survival data before deciding whether or not to approve the novel platinum compound. GPC anticipates overall survival data from the SPARC trial within six months. The firm had requested accelerated approval based on a composite progression-free survival endpoint...
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