FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
Full prescribing information for Nubeqa will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in ARANOTE (NCT02799602), a randomized, double-blind, placebo-controlled trial in 669 patients with mCSPC. Patients received either darolutamide or placebo. All patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy.
The major efficacy outcome was radiographic progression-free survival (rPFS) assessed by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. Treatment with darolutamide resulted in a statistically significant improvement in rPFS compared to placebo. Median rPFS was not reached in the darolutamide arm and was 25 months (95% CI: 19, NR) in the placebo arm (hazard ratio [HR] 0.54; 95% CI: 0.41, 0.71; p-value <0.0001). There was no statistically significant improvement in OS at the final analysis (HR 0.78; 95% CI: 0.58, 1.05).
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.
Source: Food and Drug Administration (FDA). (2025). FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer [Press release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer.
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