24 May 2013 - 24 May 2013 - Japanese Astellas Pharma Inc (TYO:4503) and US Medivation Inc (NASDAQ:MDVN) unveiled Friday the filing of a marketing approval application in Japan for Xtandi (enzalutamide) as a therapy of prostate cancer.

Enzalutamide is a novel, once-daily, oral androgen receptor signaling inhibitor.

The submission was backed by results from a double-blind, placebo-controlled Phase III study in patients with advanced castration-resistant prostate cancer who have previously undergone docetaxel-based chemotherapy, as well as Phase I and Phase II trials in advanced castration-resistant prostate cancer.

The drug was authorised in the USA in August 2012 as a therapy of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. The European Medicines Agency (EMA) is currently reviewing a marketing application for Xtandi.