GPC Biotech Withdraws Satraplatin NDA Filed for Accelerated Approval
Company Plans to Resubmit Application Pending Final Survival Analysis
GPC Biotech AG announced that it has withdrawn the satraplatin capsules New Drug Application (NDA) filed for accelerated approval for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. The Company based its decision on the vote by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (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 R. Seizinger, M.D., Ph.D., Chief Executive Officer 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."
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