ARTICLE | Clinical News

Xtandi enzalutamide regulatory update

March 31, 2014 7:00 AM UTC

Astellas said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Xtandi enzalutamide to treat castration-resistant prostate cancer (CRPC). The pharma noted that Xtandi's efficacy and safety has "not been established in patients with prostate cancer who have not received chemotherapy." The Japanese approval triggered a $15 million milestone payment to partner Medivation from the pharma. The companies partnered to develop and commercialize the oral androgen receptor antagonist in 2009 (see BioCentury, Nov. 2, 2009). ...