GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin
GPC Biotech AG announced that the Company has completed the rolling submission of a New Drug Application (NDA) to the U.S. food and Drug Administration (FDA) for satraplatin for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) who have failed prior chemotherapy. The Company submitted the third and final portion of the NDA - the clinical section, which is based primarily on data from the SPARC Phase 3 registrational trial. The trial enrolled 950 patients and showed highly statistically significant results for prolonging progression-free survival (PFS). The FDA has up to 60 days to determine whether the application meets the regulatory requirements for filing and thus will be reviewed by the agency. The Company will also be notified during that timeframe if priority review status has been granted.
"The submission of the NDA for satraplatin capsules is a major milestone in the corporate history of GPC Biotech," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "We will work closely with the FDA during the review process to move the application forward as expeditiously as possible. We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope. We are currently building our commercial infrastructure in the U.S. to prepare for the potential launch of satraplatin so that it will be available for these patients as quickly as possible."
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