Some good news for men who are living in Japan and dealing with advanced prostate cancer. It was announced that Astellas and Medivation have submitted an application for marketing approval of Enzalutamide (Xtandi) in Japan.
Their application is based on results obtained from the global Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 trial conducted in Japan. It was the AFFIRM trial that supplied the data that led to the FDA approval in the United States.
I can see no reason why the application shouldn’t be quickly approved in Japan.
Joel T Nowak, M.A., M.S.W.