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New Drug Application for Satraplatin Accepted for Priority Review
"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."
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat 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.
A Phase 3 registrational trial, called SPARC, 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.
Source: GPC Biotech AG