FDA Approves New Indication for the Use of Xtandi Capsules for Patients With Metastatic CRPC

Medivation, Inc. and Astellas Pharma Inc. has announced that FDA approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase III PREVAIL trial.

FDA initially approved Xtandi, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves Xtandi for use in men with metastatic CRPC who have not received chemotherapy. Metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone (GnRH) therapy or with removal of the testes).

"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 CRPC at all stages of their disease," said Sef Kurstjens, MD, PhD, Chief Medical Officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. "We are pleased that these patients now have Xtandi available as a treatment option."

"All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today's approval," said David Hung, MD, founder, President and CEO, Medivation, Inc. "As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see Xtandi approved in this important patient population."