FDA Approves SNDA to Update Label of Darolutamide in Non-metastatic Prostate Cancer


Darolutamide led to a 31% reduction in the risk of death, extending survival for patients with non-metastatic prostate cancer.

The FDA has approved a supplemental new drug application to add overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial (NCT02200614) to the prescribing information for darolutamide (Nubeqa) for the treatment of patients with nonmetastatic prostate cancer (nmCRPC).1

Darolutamide led to a 31% reduction in the risk of death, extending survival for patients with nmCRPC (HR, 0.69; 95% CI, 0.53-0.88; P = .003).2 The additional findings comprise time to pain progression (HR, 0.65; 95% CI, 0.53-0.79; P <.0001) and time to the initiation of cytotoxic chemotherapy (HR, 0.58; 95% CI, 0.44-0.76; P <.0001). Moreover, the prescribing information was also updated to include additional guidance on drug interactions. The final analysis of the trial reinforced the safety profile of darolutamide with an extended follow-up of median 29 months for the overall study population.

"A key goal of cancer treatment is to ensure that patients can live longer while minimizing side effects," said Scott Z. Fields, MD, senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division. “[Darolutamide] has a proven efficacy and safety profile in men with nmCRPC and delayed the effects of disease progression in men who are otherwise generally asymptomatic. This update also gives physicians added certainty that [darolutamide] should be prescribed to appropriate patients at nmCRPC diagnosis to help ensure optimal outcomes for these men.”

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