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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.


RTTNews | May 4, 2021 02:51AM EDT

02:50 Tuesday, May 4, 2021 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3191047/astellas-european-commission-approves-additional-indication-for-xtandi-quick-facts.aspx)

For comments and feedback: contact editorial@rttnews.com

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