MISSISSAUGA, ON, Aug. 21, 2025 /CNW/ - Bayer Inc. is pleased to announce that Health Canada has granted marketing authorization for its oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide)1 for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This marketing authorization is based on results from the pivotal2 Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mCSPC.
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