Japanese Approval Sought for Darolutamide in Nonmetastatic CRPC

March 3, 2019 – An application has been submitted to Japan’s Ministry of Health, Labor and Welfare for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Bayer, which codevelops the agent with Orion Corporation. The marketing authorization application is based on findings from the phase III ARAMIS study, which showed that darolutamide plus androgen deprivation therapy (ADT) had a … (leggi tutto)