FDA Approval Alert: The Need-to-Know | Darolutamide in Metastatic Castration-Sensitive Prostate Cancer

In June 2025, the FDA approved darolutamide in the treatment of patients with metastatic castration-sensitive prostate cancer.

Results from the phase 3 ARANOTE trial demonstrated a statistically meaningful improvement to rPFS with darolutamide vs placebo.
FDA OKs Darolutamide in Metastatic Castration-Sensitive Prostate Cancer
Article
Jun 3, 2025 6:39 PM
Results from the phase 3 ARANOTE trial demonstrated a statistically meaningful improvement to rPFS with darolutamide vs placebo.