FDA Alert

FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

Kate Young

On June 3, 2025, the FDA announced the approval of darolutamide for metastatic castration- sensitive prostate cancer (mCSPC), following data from the ARANOTE trial.1

This randomized, double-blind, placebo-controlled trial of 669 participants with mCSPC examined the efficacy of darolutamide by assessing progression-free survival (rPFS) using blinded independent central review.

Participants were randomized 2:1 to receive 600 mg of darolutamide or placebo alongside androgen deprivation therapy. Compared with placebo, darolutamide treatment significantly improved rPFS, and median rPFS was not reached in the darolutamide arm compared with 25 months in the placebo arm (P < .0001).2

Darolutamide is an androgen receptor inhibitor that inhibits androgen binding, androgen receptor nuclear translocation, and androgen receptor-mediated transcription. The recommended dosage is 600 mg taken orally, twice daily via two 300 mg tablets.1

The review of darolatamide was conducted under Project Orbis, an initiative launched in 2019 within the FDA Oncology Center of Excellence which allows for concurrent submission and review of oncology drugs among international partners.3

Resources:

  1. FDA approves darolutamide for metastatic castration-sensitive prostate cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer. Published June 3, 2025. Accessed June 4, 2025.
  2. U.S. FDA Approves NUBEQA (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer. https://www.bayer.com/en/us/news-stories/metastatic-castration-sensitive-prostate-cancer. Published June 3, 2025. Accessed. June 4, 2025.
  3. Project Orbis. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Published May 29, 2025. Accessed June 4, 2025.