5 October 2022 - Today's approval was based on the pivotal Phase 3 ARASENS trial, which showed a significant overall survival benefit and favourable tolerability profile with darolutamide plus androgen deprivation therapy with docetaxel compared to androgen deprivation therapy plus docetaxel.
Bayer announced today that Health Canada, following a priority review, has approved Nubeqa (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer in combination with docetaxel.
Read Bayer press release