FDA approves darolutamide

On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.

Full prescribing information for Nubeqa will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in ARANOTE (NCT02799602), a randomized, double-blind, placebo-controlled trial in 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 to placebo. Median rPFS was not reached in the darolutamide arm and was 25 months (95% 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).

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 Dosage

The recommended darolutamide dose is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until disease progression or unacceptable toxicity.

Expedited Programs

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, Switzerland’s Swissmedic, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. The application reviews are ongoing at the other regulatory agencies.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.