TOKYO, October 29, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the European Commission (EC) has approved a new indication for XTANDI (enzalutamide) for the treatment of adult men with high-risk, non-metastatic, castration-resistant prostate cancer (nmCRPC),2 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.2
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.1
"This new approval is important progress for men with CRPC, who now have enzalutamide as a treatment option regardless of whether or not they have detectable metastatic disease," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. "We are committed to working with health authorities across Europe to ensure that enzalutamide is made available as soon as possible to men with high-risk nmCRPC."
The EC marketing authorisation for enzalutamide is applicable to the 28 European Union (EU) member countries plus Iceland, Norway and Liechtenstein.3
Astellas reflected the impact from this approval its financial forecasts of the current fiscal year ending March 31, 2019
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