Medivation Inc. and Astellas Pharma Inc. Sept. 10 said that the Food and Drug Administration approved a new indication for Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).
The FDA initially approved Xtandi, an oral, once-daily androgen receptor inhibitor, in August 2012 for patients with metastatic CRPC who previously received docetaxel (chemotherapy) 10 PLIR 1165, 9/7/12. The new indication approves Xtandi for men with metastatic CRPC who haven’t 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 ...
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