Astellas: European Commission Approves Additional Indication For XTANDI - Quick Facts

Astellas Pharma Inc. (ALPMY,ALPMY) said the European Commission has approved an additional indication for the oral once-daily therapy XTANDI (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer. The approval is based on results from the phase 3 ARCHES trial which evaluated enzalutamide in men with metastatic hormone-sensitive prostate cancer.

Astellas Pharma noted that, with the 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 and mHSPC.

Astellas Pharma said the approval will have no impact on the financial forecasts of the current fiscal year.

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