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)…
