FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
On June 3, 2025, the US Food and Drug Administration (FDA) approved darolutamide for patients with metastatic castration-sensitive prostate cancer. This approval was based on results from the ARANOTE study.
In this double-blind, placebo-controlled trial, 669 patients were randomized to receive either 600 mg of twice daily darolutamide or placebo until disease progression or unacceptable toxicity. Patients were required to either receive a gonadotropin-releasing hormone analog concurrently or have undergone bilateral orchiectomy. The primary end point was radiographic progression-free survival (rPFS). Key secondary end points included overall survival (OS) and safety.
At analysis, median rPFS was not achieved in the darolutamide arm and 25 months in the placebo arm (hazard ratio [HR] 0.54; 95% confidence interval [CI], 0.41 to 0.71; P < .0001). There was no statistically significant improvement in OS at final analysis (HR 0.78; 95% CI, 0.58 to 1.05). Safety was consistent with prior findings for single agent darolutamide.
The recommended darolutamide dosage is 600 mg taken twice daily as 300 mg tablets with food until disease progression or unacceptable toxicity. Prescribing information includes warnings and precautions for ischemic heart disease, seizure, and embryo-fetal toxicity.
Source:
FDA approves darolutamide for metastatic castration-sensitive prostate cancer. Accessed on June 3, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer
