US priority review for Astellas and Medivation’s sNDA for prostate cancer

6 May 2014

Japanese drug major Astellas (TYO: 4503) US subsidiary and Medivation (Nasdaq: MDVN) revealed that the US Food and Drug Administration has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for Xtandi (enzalutamide) for treatment naive men with metastatic castration-resistant prostate cancer (mCRPC).

This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. Xtandi is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

The sNDA application is based on the results from the Phase III PREVAIL trial evaluating Xtandi as compared to placebo in more than 1,700 chemotherapy-naive mCRPC patients. A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency on April 2, 2014.

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