It comes without any great surprise, but earlier in the month the FDA announced they were giving the application from Astellas and Medivation  for a priority review to extend the indication (FDA approved use) for Xtandi  (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.  The FDA has scheduled the review for September 18, 2014.

Malecare remains optimistic that Xtandi will be approved for use prior to chemotherapy prior to the end of 2014.  If approved, it will join Provenge and Zytiga with prednisone in the pre-chemotherapy space. 

Joel T. Nowak, M.A., M.S.W..