GPC files satraplatin NDA with US FDA

German drugmaker GPC Biotech AG says that the US Food and Drug Administration has accepted its New Drug Application for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed, and granted the NDA priority review status.

GPC completed the rolling submission of the NDA for satraplatin on February 15, and the application will now be reviewed under the procedure for accelerated approval. The investigational drug is a member of the platinum family of compounds which are a critical part of modern chemotherapy treatments and are used against a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home, GPC noted.

A Phase III registrational SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.