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March 18, 2014
07:19 EDTMDVN, ALPMYMedivation, Astellas Pharma submit sNDA for XTANDI
Astellas Pharma (ALPMY) and Medivation (MDVN) announced the submission of a supplemental New Drug Application, or sNDA, to the FDA seeking approval of XTANDI capsules for the treatment of men with metastatic castration-resistant prostate cancer, or mCRPC, who have not received chemotherapy. 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 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na´ve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.
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