Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Indication for NUBEQA® (darolutamide) in Metastatic Hormone-Sensitive Prostate Cancer

  • Submission is based on positive results from the investigational pivotal Phase III ARANOTE trial that showed NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) demonstrated an improvement in radiological progression-free survival (rPFS), significantly reducing in the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT; no new safety signals were observed1
  • NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)2
Reno, Nevada (UroToday.com) -- Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. 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 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.”
The submission is based on positive results from the investigational pivotal 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

References:

  1. NUBEQA (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023.
  2. Journal of Clinical Oncology (ascopubs.org). Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. https://ascopubs.org/doi/10.1200/JCO-24-01798. September 2024.
Source: Bayer. (2024). Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Indication for NUBEQA® (darolutamide) in Metastatic Hormone-Sensitive Prostate Cancer [Press release]. https://www.bayer.com/en/us/news-stories/expanded-indication-for-nubeqar.