FDA OKs Darolutamide in Metastatic Castration-Sensitive Prostate Cancer
Results from the phase 3 ARANOTE trial demonstrated a statistically meaningful improvement to rPFS with darolutamide vs placebo.
Data from the ARANOTE trial (NCT04736199) supported the FDA approval of darolutamide in metastatic castration-sensitive prostate cancer
The FDA has approved darolutamide (Nubeqa) in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC), according to a press release from the FDA.1
Previously, the FDA approved darolutamide combined with docetaxel in mCSPC.2
Supporting results from the approval came from the randomized phase 3 ARANOTE trial (NCT04736199) that evaluated the efficacy and safety of darolutamide vs placebo; all patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy. The FDA accepted a supplemental new drug application for darolutamide based on ARANOTE.3
The median radiographic progression-free survival (rPFS) was not reached (NR) with darolutamide vs 25 months (95% CI, 19-NR) in the placebo arm (HR, 0.54; 95% CI, 0.41-0.71; P <.0001). It was also noted that, at the time of the final analysis, there was no statistically significant improvement to overall survival (OS )with darolutamide (HR, 0.78; 95% CI, 0.58-1.05).
Results from the ARANOTE trial shared at the 2025 ASCO Annual Meeting demonstrated that darolutamide and ADT improved health-related quality of life outcomes.4
The recommended dose of darolutamide is 600 mg, as two 300 mg tablets, taken orally, with food, twice daily until disease progression or unacceptable toxicity.
Regarding safety, the observed adverse events were consistent with what has been seen with darolutamide as a single agent; the darolutamide prescribing information includes warnings for ischemic heart disease, seizure, and embryo-fetal toxicityischemic heart disease, seizure, and embryo-fetal toxicity..
References
- FDA approves darolutamide for metastatic castration-sensitive prostate cancer. News release. FDA. June 3, 2025. Accessed June 3, 2025. https://tinyurl.com/yhde24zj
- FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. News release. August 5, 2022. Accessed June 3, 2025. https://bit.ly/3bvsKzF
- U.S. FDA accepts supplemental new drug application for NUBEQA® (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer. News release. Bayer. November 21, 2024. Accessed on June 3, 2025. https://tinyurl.com/36p5u9pb
- Morgans A, Haresh KP, Jievalta M, et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. J Clin Oncol. 2025;43(suppl_16):abstr 5004. doi:10.1200/JCO.2025.43.16_suppl.5004
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