Darolutamide is approved by the USFDA for metastatic castration-sensitive prostate cancer

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

Efficacy and Safety

The effectiveness was evaluated in ARANOTE (NCT02799602), a study where 669 people with metastatic castration-sensitive prostate cancer (mCSPC) were randomly assigned to receive either darolutamide or a placebo without knowing which one they got. Patients were administered either darolutamide or a placebo. All patients received a gonadotropin-releasing hormone analog simultaneously or had undergone a bilateral orchiectomy previously.

The main measure of how well the treatment worked was the time patients lived without their cancer getting worse, which was checked by an independent review team that didn’t know which treatment the patients received. Overall survival (OS) constituted an additional effectiveness endpoint. Darolutamide treatment yielded a statistically significant enhancement in rPFS relative to placebo.

The median rPFS was not attained in the darolutamide group, while it was 25 months (95% CI: 19, NR) in the placebo group (hazard ratio [HR] 0.54; 95% CI: 0.41, 0.71; p-value <0.0001). The final analysis revealed no statistically significant enhancement in overall survival (HR 0.78; 95% CI: 0.58, 1.05).

Adverse effects were consistent with previous experiences involving darolutamide as a monotherapy. The prescribing information for darolutamide contains warnings and precautions about ischemic heart disease, seizures, and embryo-fetal damage.

Suggested Dosage
The advised dosage of darolutamide is 600 mg (two 300 mg tablets) used orally, twice a day, with food, until disease progression or intolerable toxicity occurs.