Bayer submits a supplemental new drug application to the USFDA and requests an expanded indication for NUBEQA

Bayer announced the submission of a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) 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).

“Simply put, our goal is to help more patients with prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and member of the Pharmaceuticals Leadership Team at Bayer. “We are proud of the role NUBEQA currently plays in the treatment of mHSPC and hope to expand the use of NUBEQA to more patients with this disease, regardless of the use of chemotherapy, with this application to the FDA.”

The application is based on positive results from the pivotal phase III ARANOTE study. The data from the study were presented at the European Society for Medical Oncology (ESMO) Congress 2024 and published in the Journal of Clinical Oncology.

NUBEQA is being developed jointly by Bayer and Orion Corporation, a global Finnish pharmaceutical company.