June 3, 2025
Reno, Nevada (UroToday.com) -- 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.
“With today's FDA approval of doublet ADT + darolutamide for the treatment of metastatic hormone sensitive prostate cancer (mHSPC) based on the ARANOTE phase 3 trial, patients now have a treatment intensification option for mHSPC that works, is safe, and is tolerable. Today is a great day for our patients with advanced prostate cancer.” – Zachary Klaassen, MD, MSc (Urologic Oncologist, Georgia Cancer Center, Augusta University, Augusta, GA, USA, Medical Editor for Prostate Cancer Patient Voices)
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.