The Food and Drug Administration (FDA) has approved updated labeling for Nubeqa® (darolutamide; Bayer) to include additional information on overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial in men with nonmetastatic castration-resistant prostate cancer (nmCRPC).

Nubeqa, an androgen receptor inhibitor, was approved for the treatment of patients with nmCRPC based on data from the placebo-controlled phase 3 ARAMIS trial. The study evaluated the efficacy and safety of darolutamide in 1509 patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone analogue or had a bilateral orchiectomy. Patients were randomized to receive either darolutamide 600mg orally twice daily (n=955) or placebo (n=554).

Results at the time of approval demonstrated that patients treated with darolutamide plus androgen deprivation therapy (ADT) had a statistically significant improvement in metastasis free survival (MFS) with a median MFS of 40.4 months compared with 18.4 months for placebo plus ADT (hazard ratio [HR] 0.41, 95% CI (0.34, 0.50); P <.0001).

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At the protocol-specified final analysis of OS, treatment with darolutamide resulted in a statistically significant improvement in OS compared with placebo (hazard ratio [HR] 0.69; 95% CI, 0.53-0.88; =.003). Additionally, darolutamide was associated with a statistically significant delay in the time to pain progression (HR 0.65; 95% CI, 0.53-0.79; <.0001) and in the initiation of cytotoxic chemotherapy (HR 0.58; 95% CI, 0.44-0.76; <.0001). No new safety signals observed at the final analysis.

“Nubeqa 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,” said Scott Z. Fields, MD, Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. “This update also gives physicians added certainty that Nubeqa should be prescribed to appropriate patients at nmCRPC diagnosis to help ensure optimal outcomes for these men.”

The updated labeling also includes additional information on drug interactions for darolutamide with OATP1B1 and OATP1B3 transporters. Concomitant use of darolutamide may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates.

Nubeqa is supplied as 300mg film-coated tablets in 120-count bottles.

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  1. U.S. FDA approves addition of overall survival and other secondary endpoint data to Nubeqa® (darolutamide) prescribing information. [press release]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; January 8, 2021. 
  2. Nubeqa [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2021.

This article originally appeared on MPR