CHMP Recommends Expanded Use of Bayer’s Nubeqa™ (Darolutamide) for Advanced Prostate Cancer Following Positive ARANOTE Trial Results
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending Bayer’s oral androgen receptor inhibitor, darolutamide (marketed as Nubeqa™), for a third indication in the treatment of prostate cancer. The new recommendation supports the use of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union (EU). This development marks another major milestone in the evolution of Nubeqa as a critical therapeutic option in the prostate cancer landscape and extends its potential utility to a broader patient population.
Groundbreaking Data from the Phase III ARANOTE Trial
The CHMP’s recommendation is founded on data from the pivotal Phase III ARANOTE clinical trial, which demonstrated that darolutamide, when used in combination with ADT, significantly reduced the risk of radiological progression or death in patients with mHSPC. Specifically, the trial reported a 46% reduction in the risk of radiographic progression or death compared to placebo plus ADT, with a hazard ratio (HR) of 0.54 (95% CI: 0.41–0.71; P<0.0001).
The ARANOTE trial was designed to evaluate the efficacy and safety of darolutamide in a chemotherapy-free regimen for men with metastatic hormone-sensitive prostate cancer—a population in urgent need of effective, tolerable, and individualized treatment options. The strong and statistically significant results provide compelling evidence for the clinical value of darolutamide beyond its existing approvals.
Expanding Access and Personalization of Prostate Cancer Treatment
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of Bayer’s Pharmaceuticals Leadership Team, emphasized the strategic significance of this milestone. “This positive CHMP opinion reinforces darolutamide’s potential to become a leading therapy across various stages of prostate cancer and underscores our commitment to advancing innovative solutions for men living with this disease,” she stated.
Roth highlighted that if the European Commission follows CHMP’s recommendation, darolutamide could be used with or without chemotherapy for mHSPC patients in Europe. This would greatly expand the range of therapeutic options available and allow physicians greater flexibility to tailor treatment plans to the unique needs and preferences of their patients.
Dr. Fred Saad, Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and the Principal Investigator of the ARANOTE trial, added further context on the clinical implications. “Results from the ARANOTE trial show darolutamide plus ADT significantly reduces the risk of radiological progression or death. As the first androgen receptor inhibitor with clinically meaningful health-related quality of life benefits, this new treatment option could further empower physicians to better personalize care and improve outcomes for their patients,” Saad said.
Next Steps in the Regulatory Process
Following the CHMP recommendation, a final decision from the European Commission regarding marketing authorization is expected in the coming months. Should the Commission adopt the recommendation, it will grant marketing approval valid across all EU member states as well as Iceland, Liechtenstein, and Norway.
Meanwhile, the U.S. Food and Drug Administration (FDA) already approved darolutamide in combination with ADT for mHSPC in June 2025. This made it the first androgen receptor inhibitor approved in the U.S. for use in mHSPC patients in combination with ADT, regardless of whether chemotherapy is part of the regimen. This regulatory milestone in the U.S. sets a precedent and adds momentum to darolutamide’s global footprint.
A Growing Legacy of Approvals for Darolutamide
Darolutamide, marketed under the brand name Nubeqa™, is now approved in more than 85 countries worldwide. These approvals span a variety of indications, including use in combination with ADT and docetaxel for the treatment of mHSPC, as well as for use with ADT alone in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of progressing to metastatic disease.
The growing body of clinical evidence continues to demonstrate the versatility and tolerability of darolutamide across different stages and types of prostate cancer. Its unique molecular structure offers several potential advantages, including a lower risk of crossing the blood-brain barrier, which may contribute to a favorable safety and tolerability profile compared to other androgen receptor inhibitors.
The Urgent Need for New Prostate Cancer Therapies
The need for innovative therapies in prostate cancer remains critical. Prostate cancer is the second most commonly diagnosed cancer in men globally and the fifth leading cause of cancer-related death among men. In 2022 alone, approximately 1.5 million men were diagnosed with prostate cancer worldwide, and nearly 397,000 succumbed to the disease.
In Europe, the burden is similarly significant, with an estimated 474,000 new cases and approximately 115,000 deaths reported in 2022. As population aging and better diagnostic measures increase detection rates, projections indicate that prostate cancer cases could rise to 2.9 million annually by 2040.
Given these sobering statistics, the role of therapies like darolutamide in improving survival outcomes and quality of life for men with prostate cancer cannot be overstated.
Collaborative Development with Orion Corporation
Darolutamide was co-developed by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company with a strong focus on oncology and urology. The partnership has proven instrumental in advancing darolutamide through clinical development and regulatory processes worldwide.
This latest CHMP recommendation marks another successful chapter in the collaboration and reinforces the strength of the development program behind darolutamide, which has consistently delivered robust clinical data to support broader use.
The CHMP’s recommendation to expand the use of Bayer’s darolutamide to include patients with metastatic hormone-sensitive prostate cancer represents a major advancement in the ongoing fight against prostate cancer. Backed by strong clinical data from the ARANOTE trial, this decision has the potential to transform the treatment landscape for a substantial patient population.
Pending final approval by the European Commission, darolutamide in combination with ADT could soon become a new standard of care for mHSPC patients across the EU, with or without chemotherapy. As prostate cancer incidence continues to rise globally, such advances are critical in offering more effective, safer, and personalized treatment options for patients around the world.
