FDA Approves Nubeqa (Darolutamide) for Expanded mCSPC Indication

On June 3, 2025, the FDA expanded the indication for darolutamide (Nubeqa), approving it as a first-line therapy for patients with metastatic castration-sensitive prostate cancer (mCSPC), with or without chemotherapy. This approval was based on robust results from the Phase III ARANOTE trial, demonstrating a 46% reduction in the risk of radiographic progression or death compared to androgen deprivation therapy (ADT) alone (HR 0.54; 95% CI, 0.41-0.71; p<0.0001). While overall survival data are still maturing, this expanded indication significantly broadens the treatment landscape, providing clinicians and patients additional effective options for managing newly diagnosed mCSPC.

Citation: ASCO Post, June 2025. Available at: https://ascopost.com/issues/june-25-2025/fda-approves-darolutamide-for-metastatic-castration-sensitive-prostate-cancer

Implication: This label expansion further diversifies frontline treatment options, intensifying competition among androgen receptor inhibitors (ARIs).