Xtandi enzalutamide regulatory update

Medivation and Astellas said EMA’s CHMP recommended approval of a Type II variation for Xtandi enzalutamide to update the label to include Phase II data comparing Xtandi vs. Casodex bicalutamide in patients with metastatic castration-resistant prostate cancer (CRPC). Data from the Phase II TERRAIN trial showed that Xtandi met the primary endpoint of improving median progression-free survival (PFS) vs. Casodex in CRPC patients whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analog therapy or following surgical castration (see BioCentury, Feb. 2, 2015). ...