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

Astellas Pharma announced today that the European Commission has approved a new indication for Xtandi (enzalutamide) for the treatment of adult men with high-risk, non-metastatic, castration-resistant prostate cancer (nmCRPC), making it 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 already 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.

The approval is based on the results from the pivotal phase 3 PROSPER trial which evaluated enzalutamide plus ADT vs. placebo plus ADT in patients with nmCRPC and rapidly rising prostate-specific antigen (PSA) levels, as defined by a PSA doubling time of 10 months or less and a PSA level of ≥ 2 ng/mL.

Read Astellas press release