Bayer announced that the FDA 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).
“Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today’s acceptance of our sNDA application for NUBEQA plus ADT for the treatment of patients with mHSPC brings us closer to adding an additional treatment option for NUBEQA to benefit those living with mHSPC,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, this would expand the indication for NUBEQA in patients with mHSPC to include NUBEQA both with and without chemotherapy, providing physicians and their patients with an additional NUBEQA treatment option in this setting. We are working closely with the FDA to bring this additional NUBEQA treatment option to patients as soon as possible.”
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.
NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
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