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U.S. FDA Approves Third Indication of Darolutamide for Patients with Advanced Prostate Cancer
- On June 3, 2025, the U.S. FDA approved darolutamide for treating metastatic castration-sensitive prostate cancer, expanding its indications in the U.S.
- This approval followed positive results from the phase 3 ARANOTE trial, which showed darolutamide plus androgen deprivation therapy significantly improved progression-free survival.
- In the trial, 446 patients received darolutamide plus ADT and did not reach median radiographic progression-free survival, compared with 25 months in 223 placebo patients.
- Darolutamide reduced the risk of radiographic progression or death by 46% versus placebo , while maintaining quality of life and delaying pain progression.
- The approval offers a new oral treatment option with a favorable safety profile for men with mCSPC and reflects ongoing regulatory reviews in other countries under Project Orbis.
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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.
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
·New York, United States
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R 25%
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