FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

Darolutamide (Nubeqa; Bayer Healthcare Pharmaceuticals) has been approved by the FDA for metastatic castration-sensitive prostate cancer (mCSPC), following an earlier approval to be used in combination with docetaxel for mCSPC.¹

The treatment was assessed in ARANOTE (NCT02799602), a double-blind, placebo-controlled trial in 669 patients with mCSPC, in which participants were randomly assigned to either darolutamide or placebo. All patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy.

Treatment with darolutamide resulted in a statistically significant improvement in radiographic progression-free survival (rPFS) when compared with placebo. Median rPFS was not reached in the darolutamide arm and was 25 months (95% confidence interval, 19-not reached) in the placebo arm. There was no statistically significant improvement in overall survival at the final analysis. Adverse reactions were consistent with prior experience with darolutamide as a single agent. The darolutamide prescribing information includes warnings and precautions for ischemic heart disease, seizure, and embryo-fetal toxicity.

Reference

1. FDA. FDA approves darolutamide for metastatic castration-sensitive prostate cancer [press release]. June 3, 2025. Accessed July 1, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer