GPC Biotech Withdraws Satraplatin NDA

GPC Biotech announced that it has withdrawn the satraplatin capsule new drug application (NDA) filed for accelerated approval for the treatment of hormone-refractory prostate cancer in patients whose prior chemotherapy failed. 

GPC said it based its decision on the vote by the FDA’s Oncologic Drugs Advisory Committee July 24 that the FDA should wait for the final survival analysis of the Phase III SPARC trial before deciding whether satraplatin is approvable.

The company said it anticipates overall survival results from the SPARC trial to be available within six months. However, the timing is based on an extrapolation of death rates in the trial and may change.