On June 3, 2025, Nubeqa® (darolutamide) received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), a type of advanced prostate cancer that has spread from the prostate into other parts of the body. Nubeqa® was previously FDA-approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and as part of a combination treatment in adult patients with metastatic castration-sensitive prostate cancer (mCSPC) with docetaxel, a chemotherapy drug given intravenously (IV). The expanded indication in adult patients with mCSPC allows for use of Nubeqa® oral tablets without the coadministration of IV docetaxel, providing patients the opportunity to self-administer their medication at home. The recommended dose of Nubeqa® for treatment of mCSPC is 600mg taken by mouth twice daily with food.
The safety and efficacy of Nubeqa® single-drug therapy for the treatment of mCSPC was tested in a randomized, double-blind, placebo-controlled trial of 669 patients. The primary efficacy outcome was progression-free survival as evidenced using radiographic imaging. Compared to placebo, treatment with Nubeqa® resulted in a statistically significant improvement in patient outcome. Common side effects of Nubeqa® include fatigue, constipation, rash, high blood pressure and bleeding. Warnings and precautions for use of Nubeqa® include risk of fetal harm or loss of pregnancy if pregnant women are exposed to the drug. Nubeqa® may also cause serious side effects, such as ischemic heart disease (blockage of the arteries in the heart) and seizures. The manufacturer recommends patients contact their health care provider right away if they experience any of these serious side effects while receiving treatment with Nubeqa®.