FDA accepts sNDA for Nubeqa (darolutamide) plus ADT to treat metastatic hormone-sensitive prostate cancer – Bayer

Bayer  announced that the  FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Nubeqa is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The sNDA application is based on positive results from the Phase III ARANOTE trial. Data from the trial were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology. (previously cited). NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.