• FDA approves darolutamide for metastatic prostate cancer subset

    6 days ago - By Healio

    The FDA approved darolutamide tablets in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer.
    Darolutamide is an androgen receptor 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
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