FDA approves sNDA for Nubeqa to add OS Rxing info

9 January 2021

The US Food and Drug Administration has 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, German pharma and crop sciences major Bayer (BAYN: DE) announced late Friday.

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, said Bayer.

The updated Prescribing Information follows the presentation of these data at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program and subsequent September 10 publication in The New England Journal of Medicine.

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