Bayer Files sNDA for NUBEQA Expansion

Bayer has announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for NUBEQA (darolutamide), an oral androgen receptor inhibitor (ARi). The application seeks approval for the use of NUBEQA in combination with androgen deprivation therapy (ADT) to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of Bayer's Pharmaceuticals Leadership Team, expressed the company's commitment to expanding treatment options for prostate cancer patients. "Our goal is to help more prostate cancer patients," Roth said. "We are proud of NUBEQA's current role in mHSPC treatment and hope this FDA submission will enable more patients, with or without chemotherapy, to benefit from it."

The submission is supported by positive outcomes from the pivotal Phase III ARANOTE trial. Results from this study were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology. NUBEQA is being co-developed by Bayer and Finland-based pharmaceutical company Orion Corporation.