FDA Accepts Satraplatin NDA For Filing And Grants Priority Review Status
Prostate Cancer Drug
Food and Drug Administration has accepted for filing the Company's New Drug Application for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer whose prior chemotherapy has failed.
The Company also announced that the FDA has granted the NDA priority review status. Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission. GPC Biotech completed the rolling submission of the NDA for satraplatin on February 15, 2007. The application will be reviewed under the provisions of 21 CFR 314 Subpart H, for accelerated approval.
"We are pleased that the FDA has accepted our application for filing and granted it priority review status. We look forward to working closely with the agency during the review process," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With the designation of priority review, we expect an action on the application from the FDA in August of this year and are thus moving forward with commercialization plans for satraplatin. If approved, we believe that satraplatin has the potential to become an important therapy for hormone-refractory prostate cancer patients whose disease has progressed after prior chemotherapy, an area of unmet medical need."