27 January 2023 - CHMP recommendation is based on Phase 3 data, which demonstrated that darolutamide plus androgen deprivation therapy in combination with docetaxel significantly reduced the risk of death by 32.5% compared to androgen deprivation therapy with docetaxel alone, with similar overall rates of adverse events between study arms.

The CHMP of the EMA has recommended darolutamide, an oral androgen receptor inhibitor, plus androgen deprivation therapy in combination with docetaxel for marketing authorisation in the European Union for the treatment of patients with metastatic hormone-sensitive prostate cancer.

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