FDA Approves Nubeqa for Metastatic Castration-Sensitive Prostate Cancer

The FDA has approved darolutamide (Nubeqa, Bayer) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.

Efficacy was evaluated in ARANOTE (ClinicalTrials.gov Identifier: 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