FDA accepts Bayer’s application to expand NUBEQA’s use in prostate cancer treatment
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for NUBEQA (darolutamide), potentially broadening its use for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Currently approved for mHSPC in combination with docetaxel, this new submission aims to extend NUBEQA’s indication for use alongside androgen deprivation therapy (ADT) alone. If […]