FDA Approves Darolutamide for Metastatic Prostate Cancer

On June 3, 2025, the Food and Drug Administration (FDA) announced the approval of darolutamide, marketed as Nubeqa by Bayer Healthcare Pharmaceuticals Inc., for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). This approval expands the indications for darolutamide, which the FDA had previously approved for use in combination with docetaxel for the same condition. The detailed prescribing information will be made available on Drugs@FDA.

The efficacy of darolutamide was demonstrated in the ARANOTE trial (NCT02799602), a well-structured, randomized, double-blind, placebo-controlled study involving 669 participants diagnosed with mCSPC. Participants in the study were assigned to receive either darolutamide or a placebo, alongside a gonadotropin-releasing hormone analog, or following a prior bilateral orchiectomy to manage their condition. The primary measure of the trial’s success was radiographic progression-free survival (rPFS), which was evaluated through a blinded independent central review. Overall survival (OS) was also considered as an additional measure of efficacy.

The results of the trial revealed that darolutamide significantly improved rPFS when compared to the placebo. While the median rPFS was not reached in patients receiving darolutamide, the median rPFS for the placebo group was 25 months. The hazard ratio was calculated at 0.54 with a 95% confidence interval ranging from 0.41 to 0.71, and the associated p-value was less than 0.0001, indicating strong statistical significance. However, no statistically meaningful difference in overall survival was observed at the point of the final analysis, with a hazard ratio of 0.78 and a 95% confidence interval between 0.58 and 1.05.

The safety profile of darolutamide in this setting was consistent with previous observations when used as a single agent. The prescribing information for darolutamide contains important warnings and precautions regarding the risk of ischemic heart disease, the potential for seizures, and the dangers of embryo-fetal toxicity.

For patients, the recommended dose of darolutamide is 600 mg, administered as two 300 mg tablets taken orally twice a day with food. The treatment should continue until the disease progresses or the patient experiences unacceptable toxicity levels.

The review process for this approval was conducted under Project Orbis, an FDA initiative led by the Oncology Center of Excellence. Project Orbis allows for the simultaneous submission and evaluation of oncology drugs by various international regulatory bodies. For this particular review, the FDA collaborated with regulatory agencies from Australia, Canada, Switzerland, and the United Kingdom. The application is still under review by some of these partner agencies.

Healthcare providers are encouraged to report any serious adverse effects potentially linked to the use of medications or devices to the FDA’s MedWatch Reporting System. This initiative helps ensure patient safety and the monitoring of new treatments once they enter the market. The FDA remains committed to facilitating the availability of effective oncology treatments and supports healthcare professionals in managing patients with challenging cancer diagnoses.