FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

On June 3, 2025, the FDA approved darolutamide (Nubeqa) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). This oral androgen receptor inhibitor demonstrated a significant improvement in radiographic progression–free survival compared to placebo in a phase III trial. However, no statistically significant improvement in overall survival was observed. Adverse reactions were consistent with prior experience, and the prescribing information includes warnings for ischemic heart disease, seizure, and embryo-fetal toxicity.