- Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC) the opportunity to extend their lives1
- Time to pain progression, a key secondary endpoint, is meaningful for men living with nmCRPC and an important consideration in treatment decisions1
- The final analysis reinforced NUBEQA’s safety profile with longer term follow-up1,2
San Francisco, CA (UroToday.com) — Bayer announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to add overall survival (OS) and other secondary endpoint data from the Phase III 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 (nmCRPC) 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. The final analysis reinforced NUBEQA’s safety profile with an extended follow-up of median 29 months for the overall study population.1,2