FDA approves sNDA to add additional prescribing data on Nubeqa in treatment for prostate cancer.- Bayer

Bayer announced that the 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.Previously published results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with Nubeqa plus androgen deprivation therapy (ADT), compared to 18.4 months (n=554) for placebo plus ADT (p<0.001). mfs is defined as the time from randomization to the time of first evidence of blinded independent central review (bicr)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.>