
The FDA approved darolutamide tablets in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer.
Darolutamide (Nubeqa, Bayer) is an androgen receptor (AR) inhibitor designed to inhibit androgen binding, AR nuclear translocation and AR-mediated transcription.
The FDA based the approval on results of the randomized phase 3 ARASENS trial, which included 1,306 men with newly diagnosed metastatic hormone-sensitive prostate cancer.
Researchers assigned men to androgen deprivation therapy and docetaxel plus either 600 mg darolutamide twice daily or placebo.
OS served as the