8 January 2021 - Phase 3 data showed treatment with Nubeqa resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer the opportunity to extend their lives.

Bayer today announced that the U.S. FDA approved a supplemental new drug application to add overall survival and other secondary endpoint data from the Phase 3 ARAMIS trial to the Nubeqa (darolutamide) Prescribing Information. 

Nubeqa significantly reduced the risk of death by 31%, offering men with non-metastatic castration-resistant prostate cancer extended survival for a greater chance of living longer. 

Additional data include time to pain progression and time to initiation of cytotoxic chemotherapy. The Prescribing Information was also updated to include additional guidance on drug interactions.

Read Bayer press release