RTTNews | Mar 26, 2021 09:26AM EDT

09:25 Friday, March 26, 2021 (RTTNews.com) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDI or enzalutamide for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).

Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.

If approved by the European Commission, enzalutamide will be 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.3 The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.

Enzalutamide is currently approved in the EU for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and adult men with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not yet clinically indicated, or following disease progression on or after docetaxel therapy.

Read the original article on RTTNews ( https://www.rttnews.com/3180617/astellas-gets-positive-chmp-opinion-for-xtandi-on-metastatic-hormone-sensitive-prostate-cancer.aspx)

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