Xtandi enzalutamide regulatory update

Astellas and Medivation said FDA accepted for review an sNDA 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). The PDUFA date is Oct. 22. Data from the Phase II TERRAIN and STRIVE trials both 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; March 30, 2015 & April 13, 2015). ...