25 September 2018 - Results from the PROSPER trial show a median metastasis-free survival of 36.6 months for enzalutamide plus androgen deprivation therapy vs 14.7 months for men who received placebo plus androgen deprivation therapy.

Astellas Pharma announced today that the CHMP of the EMA has adopted a positive opinion to expand the indication for Xtandi (enzalutamide) to include adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). If approved by the European Commission (EC), enzalutamide will be one of the first treatments approved for this critical stage of disease, currently associated with a significant unmet medical need. 

Enzalutamide was first approved by the EC in June 2013 and is currently indicated in the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated or whose disease has progressed on or after docetaxel therapy.

Read Astellas press release