U.S. FDA Approves Third Indication of Darolutamide for Patients with Advanced Prostate Cancer

FDA expands darolutamide indication for advanced prostate cancer

The FDA has approved darolutamide without chemotherapy for treatment of metastatic hormone-sensitive prostate cancer.The FDA based its approval off results from the randomized phase 3 ARANOTE trial, which showed darolutamide (Nubeqa, Bayer), an androgen receptor inhibitor, plus androgen deprivation therapy (ADT) significantly improved radiographic PFS compared with placebo plus ADT.

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI & INDIANAPOLIS--(BUSINESS WIRE)--Jun 4, 2025-

U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer

ORION CORPORATION PRESS RELEASE 3 JUNE 2025 at 23.30 EEST           U.S. FDA approves third indication of darolutamide for patients with advanced...

Darolutamide Now Approved as Single Agent for Metastatic Castration–Sensitive Prostate Cancer

The FDA approval is based on safety and efficacy demonstrated in the phase 3 ARANOTE trial, which evaluated darolutamide — without docetaxel chemotherapy — vs placebo. Medscape Medical News

Darolutamide Gains FDA Approval for Metastatic Castration-Sensitive Prostate Cancer

Darolutamide (Nubeqa) is granted FDA approval for metastatic castration-sensitive prostate cancer, enhancing survival and quality of life for patients.

Darolutamide Receives FDA Approval for mCSPC

The FDA approved darolutamide monotherapy for use in metastatic hormone-sensitive prostate cancer following ARANOTE findings.