Posted by Michael Wonder on 22 Aug 2025
Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer
21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.
This marketing authorisation is based on results from the pivotal Phase 3 ARANOTE trial, which showed that darolutamide plus androgen deprivation therapy reduced the risk of radiological progression or death by 46% compared to placebo plus androgen deprivation therapy (HR 0.54; 95%CI 0.41–0.71; P<0.0001) in patients with metastatic castration-sensitive prostate cancer.
