GPC Biotech files NDA for satraplatin
Germany's GPC Biotech AG has completed the rolling submission of a New Drug Application to the US Food and Drug Administration for satraplatin in 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 III registrational trial. This enrolled 950 patients and showed highly statistically-significant results for prolonging progression-free survival. 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. GPC will also be notified during that timeframe if priority review status has been granted.
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