FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

1. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer. 2. Significant improvement in radiographic progression–free survival was observed in a phase III trial. 3. No statistically significant improvement in overall survival. 4. Adverse reactions consistent with prior experience. 5. Prescribing information includes warnings for ischemic heart disease, seizure, and embryo-fetal toxicity.