FDA Expands Approval of Bayer’s Nubeqa for Prostate Cancer

The FDA has expanded its approval of Bayer’s cancer drug Nubeqa (darolutamide), this time approving the drug in combination with the chemotherapy drug docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

Nubeqa works by preventing male sex hormones from binding to proteins called androgen receptors, which are found in normal prostate cells and some prostate cancer cells.

The expanded approval was based on study results showing improved overall survival in treated patients. Nubeqa combined with androgen deprivation therapy and docetaxel reduced the risk of death by 32 percent.

The oral drug was first approved in July 2019 for the treatment of adult patients with non-metastatic castration-resistant prostate cancer.