Metastatic Castration-Resistant Prostate Cancer Gets New Therapy, As FDA Approves XTANDI

Metastatic Castration-Resistant Prostate Cancer Gets New Therapy, As FDA Approves XTANDI
EnzalutamideAstellas Pharma Inc. and Medivation, Inc. have announced that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (mCRPC). This new approval is based on a priority review of the supplemental New Drug Application (sNDA) that was based on results from the Phase 3 PREVAIL trial. Enzalutamide, or XTANDI, is an oral, once-daily androgen receptor inhibitor that acts on three different steps in the androgen receptor signaling pathway and it was first approved by the FDA in August 2012 for use in patients with mCRPC who previously received docetaxel, a drug used in chemotherapy. With this new approval, XTANDI can also be used in men suffering from mCRPC who have not received chemotherapy. “The FDA’s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease. We are pleased that these patients now have XTANDI available as a treatment option," Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. said in a
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