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news.GPC Biotech has withdrawn its new drug application for accelerated approval which it had filed for prostate cancer drug satraplatin.
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The company based its decision on the vote by the oncologic drugs advisory committee (ODAC) to the FDA on July 24, 2007 that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable.
The company anticipates overall survival results from the SPARC trial to be available within six months. However, this timing is based on an extrapolation of death rates in the trial and may change.
“While we were very surprised and disappointed by last week’s ODAC outcome, we need to move forward,” said Bernd Seizinger, CEO of GPC Biotech. “Thus, we are focusing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission. If these data are positive, we plan to submit an NDA to the FDA as quickly as possible.”
Satraplatin, which GPC licensed from Spectrum Pharmaceuticals, has also been accepted in Europe for a marketing authorization review.
A Phase III registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. Patients who have not progressed continue to be treated and all patients are being followed for overall survival.