ALPMF - Astellas Pharma's Xtandi OK'd in Europe for prostate cancer

The European Commission ((EC)) has approved an additional indication for Astellas Pharma's (ALPMF) oral once-daily therapy Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC). The EC approval is based on results from the Phase 3 ARCHES trial which evaluated enzalutamide in men with mHSPC. Data showed that enzalutamide plus androgen deprivation therapy ((ADT)) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT.With this indication, enzalutamide is now the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer ((CRPC)) and mHSPC. This approval will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.

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Astellas Pharma's Xtandi OK'd in Europe for prostate cancer