MDV 3100 (Astellas) for Prostate Cancer submitted to EMA for marketing authorisation - 28-Jun-2012

Astellas has submitted a European marketing authorisation application to the EMA for MDV 3100 (enzalutamide) for the treatment of men with metastatic castration-resistant Prostate Cancer who have been previously treated with docetaxel-based chemotherapy. The submission follows positive results from the pivotal Phase III AFFIRM study, which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival with a median improvement over placebo of 4.8 months. The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints. A New Drug Application has been submitted in the US, where priority review of the compound has been requested.