Androgen Receptor Inhibitor OK’d for mCSPC Free

The FDA today approved Bayer’s darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC) with or without chemotherapy. The decision was based on the results of the phase III ARANOTE trial, in which researchers randomly assigned 669 patients in a 2:1 fashion to receive the androgen receptor inhibitor plus androgen deprivation therapy or a placebo plus androgen deprivation therapy. Darolutamide reduced the risk of disease progression or death by 46% compared with the placebo. Separately, during the 2025 American Society of Clinical Oncology’s Annual Meeting, held May 30–June 3, researchers reported better health-related quality-of-life among patients who received darolutamide in the ARANOTE trial.