New Hormone Therapy for Metastatic Castration-sensitive Prostate Cancer
The FDA has approved darolutamide for metastatic castration-sensitive prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved darolutamide (Nubeqa) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Darolutamide is an inhibitor of the testosterone-binding androgen receptor. Prostate cancers often harness this signaling pathway to drive tumor growth, and mCSPC tumors are defined as those that still respond to androgen deprivation therapy, which suppresses testosterone signaling. Darolutamide was previously approved in combination with chemotherapy for patients with metastatic hormone-sensitive prostate cancer and as a single agent for patients with nonmetastatic castration-resistant prostate cancer.
This recent approval is based on results from the randomized, double-blind, placebo-controlled, global phase III ARANOTE trial, in which 669 patients with mCSPC were randomly assigned (2:1) to receive darolutamide or placebo. Patients also concurrently received a gonadotropin-releasing hormone analog, unless they previously had both testicles removed.
At median follow-ups of 25.3 months and 25 months in the darolutamide and placebo arms, respectively, the tumors of patients in the darolutamide arm were 46% less likely to progress compared to the tumors of patients in the placebo arm. While half of patients in the placebo arm experienced disease progression by 25 months, the median progression-free survival was not reached in the darolutamide arm.
The recommended dose for darolutamide is two 300 mg tablets twice daily with food until disease progression or unacceptable toxicity.
Prostate cancer is the most common non-skin cancer diagnosed in men, and the majority of cases are castration-sensitive; roughly 10% to 20% of prostate cancers will become castration-resistant within five years. According to federal statistics, it was estimated that 313,780 individuals would be diagnosed with prostate cancer and approximately 35,770 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on June 3, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.