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news.Astellas Pharma and Medivation have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking approval of Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.
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Currently, Xtandi is approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.
The sNDA is based on the results from the Phase III PREVAIL trial evaluating Xtandi as compared to placebo in over 1,700 chemotherapy-naïve mCRPC patients.
The company also intends to submit marketing authorization application for the drug to the European Medicines Agency (EMA) later in 2014.
The randomized, double-blind, placebo-controlled, multi-national Phase III PREVAIL trial enrolled patients with chemotherapy-naïve metastatic prostate cancer whose disease progressed on a luteinizing hormone-releasing hormone analogue or after bilateral orchiectomy.
The trail was carried out at sites in the US, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan.
Co-primary endpoints of the trial were overall survival and radiographic progression-free survival.
The trial was designed to assess enzalutamide at a dose of 160mg taken orally once daily versus placebo.