Darolutamide approved for metastatic castration-resistant prostate cancer

FDA approved Nubeqa (darolutamide) for metastatic castration-sensitive prostate cancer (mCSPC). The agency previously approved darolutamide in combination with docetaxel for mCSPC.

Efficacy

Efficacy was evaluated in the randomized, double-blind, placebo-controlled ARANOTE trial (NCT04736199) involving 669 patients with mCSPC. Patients received either darolutamide or placebo. All patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy.

The major efficacy outcome was radiographic progression-free survival (rPFS) assessed by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. Treatment with darolutamide resulted in a statistically significant improvement in rPFS compared with placebo. Median rPFS wasn’t reached in the darolutamide arm and was 25 months (95% confidence interval [CI], 19, NR) in the placebo arm (hazard ratio [HR], 0.54; 95% CI, 0.41, 0.71; p-value <0.0001). There was no statistically significant improvement in OS at the final analysis (HR, 0.78; 95% CI, 0.58, 1.05).

Safety

Adverse reactions were consistent with prior experience with darolutamide as a single agent. The darolutamide Prescribing Information includes warnings and precautions for ischemic heart disease, seizure, and embryo-fetal toxicity.

Recommended dose

The recommended dosage of darolutamide is 600 mg (two 300 mg tablets) PO bid with food until disease progression or unacceptable toxicity.

Sources:

FDA approves darolutamide for metastatic castration-sensitive prostate cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer

US FDA approves Nubeqa® (darolutamide) to treat patients with metastatic castration-sensitive prostate cancer. [News release]. 2025. https://www.bayer.com/en/us/news-stories/metastatic-castration-sensitive-prostate-cancer

Nubeqa (darolutamide) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf Revised June 2025. Accessed June 6, 2025.