Bayer’s Nubeqa Secures Third FDA Approval, Expanding Prostate Cancer Treatment Landscape
Bayer has announced that the U.S. Food and Drug Administration (FDA) has granted approval for a third indication of its oral androgen receptor inhibitor, Nubeqa™ (darolutamide). This latest approval allows for the use of Nubeqa in combination with androgen deprivation therapy (ADT) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The green light from the FDA is grounded in the positive findings of the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide combined with ADT reduced the risk of radiological disease progression or death by 46% compared to ADT alone. This was evidenced by a hazard ratio (HR) of 0.54, with a 95% confidence interval (CI) of 0.41–0.71, and a highly significant P-value of <0.0001.
With this expanded indication, Nubeqa plus ADT is now approved in the U.S. for adult patients with mHSPC, regardless of whether or not they are receiving docetaxel chemotherapy. The drug is also approved for non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of metastasis, broadening the range of treatment options available for various stages of prostate cancer.
Strong Clinical Data Supports Broader Use of Nubeqa
Dr. Fred Saad, Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), who also served as Principal Investigator for the ARANOTE trial, emphasized the relevance of the new data. “Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with ADT,” he noted.
This most recent FDA approval builds upon previous findings from the ARASENS trial, in which darolutamide combined with ADT and docetaxel also showed strong clinical benefits. According to Dr. Saad, “Combined with the strong clinical efficacy demonstrated in the ARASENS trial, today’s approval further expands options for how physicians can use Nubeqa in the treatment of mHSPC, giving them greater flexibility in choosing treatment plans for their patients.”
The ARANOTE trial enrolled patients who had not previously received systemic therapy for mHSPC and were not candidates for docetaxel. The trial results show that even without chemotherapy, Nubeqa plus ADT can deliver substantial clinical benefits in terms of delaying disease progression and reducing mortality risk.
Addressing a Global Health Burden
Prostate cancer continues to be a major global health challenge. It ranks as the second most commonly diagnosed cancer in men and is the fifth leading cause of cancer-related deaths among males worldwide. According to global cancer statistics, approximately 1.5 million men were diagnosed with prostate cancer in 2022, and the disease was responsible for about 397,000 deaths.
Looking ahead, the number of prostate cancer diagnoses is projected to nearly double to 2.9 million by 2040, driven by aging populations and improved diagnostic capabilities. This rising incidence heightens the urgency for innovative therapies that can effectively delay disease progression and preserve patients’ quality of life.
A Patient-Centered Approach to Prolonging Life
For many patients with mHSPC, maintaining an active lifestyle while undergoing treatment is a top priority. Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of Bayer’s Pharmaceuticals Leadership Team, underscored this need. “Patients with mHSPC want treatments that delay disease progression and extend life—without compromising their ability to stay active,” she said.
Roth highlighted that the new FDA approval is more than a regulatory milestone; it’s a reaffirmation of Bayer’s ongoing mission to provide meaningful clinical benefits. “This approval, supported by compelling clinical data, reaffirms Nubeqa’s potential to become a leading therapy across various stages of prostate cancer,” she added. “It underscores our commitment to deliver meaningful outcomes for patients and their loved ones.”
Nubeqa’s Expanding Global Footprint
The U.S. FDA’s latest approval further solidifies Nubeqa’s status as a global prostate cancer therapy. The drug is now approved for use in over 85 countries for patients with mHSPC in combination with ADT and docetaxel. In addition, it is approved in more than 85 markets for the treatment of patients with nmCRPC who are at high risk of developing metastatic disease.
Notably, Bayer is also pursuing regulatory approval in the European Union for darolutamide in combination with ADT alone (without docetaxel) for the treatment of mHSPC. If approved, this would further extend access to patients across the EU, adding to Nubeqa’s growing therapeutic footprint.
Darolutamide distinguishes itself from other androgen receptor inhibitors through its unique molecular structure, which is designed to minimize penetration of the blood-brain barrier, potentially reducing central nervous system-related side effects. This safety profile has made it a particularly appealing option for long-term use in patients with earlier-stage or hormone-sensitive prostate cancer.
Bayer’s Commitment to Prostate Cancer Innovation
The expansion of Nubeqa’s indications is part of Bayer’s broader strategic commitment to oncology innovation, particularly in the area of genitourinary cancers. The company continues to invest in clinical trials and real-world data generation to explore additional applications and combination therapies for darolutamide.
By addressing unmet medical needs across the prostate cancer continuum—from non-metastatic to metastatic disease states—Bayer aims to deliver personalized, evidence-based treatment options tailored to the evolving needs of patients. The inclusion of Nubeqa as a potential option both with and without chemotherapy allows oncologists greater latitude to develop individualized treatment plans.
The FDA’s approval of darolutamide (Nubeqa) in combination with ADT for the treatment of metastatic castration-sensitive prostate cancer marks a significant advancement in the management of prostate cancer. Backed by robust evidence from the ARANOTE trial and building upon earlier ARASENS data, this latest milestone not only extends Nubeqa’s reach across different disease states but also enhances the therapeutic arsenal available to oncologists.
With a strong safety and efficacy profile, growing global approvals, and ongoing regulatory reviews, Nubeqa is quickly cementing its role as a cornerstone therapy in the evolving treatment paradigm of prostate cancer. As incidence rates continue to rise globally, Bayer’s continued innovation in this space offers renewed hope for patients and families impacted by this challenging disease.
