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), in combination with androgen deprivation therapy (ADT). The application seeks to expand Nubeqa's indication to include the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The sNDA is supported by data from the pivotal Phase III ARANOTE trial. The results of this trial were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and subsequently published in The Journal of Clinical Oncology.
Clinical Data from the ARANOTE Trial
The ARANOTE trial evaluated the efficacy and safety of Nubeqa in combination with ADT in mHSPC patients. The study's findings demonstrated a statistically significant improvement in the primary endpoint. Further details on the specific data and statistical significance can be found in the publication from The Journal of Clinical Oncology.
Current Indications and Future Potential
Nubeqa is currently approved for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC). This sNDA represents Bayer's commitment to expanding the therapeutic potential of Nubeqa to a broader patient population.
"Simply put, our ambition 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 with this FDA submission, hope to expand the use of NUBEQA to more patients with the disease, regardless of chemotherapy use."
Collaboration
NUBEQA is being jointly developed by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
