Health Canada grants marketing authorization for an additional indication of Bayer’s NUBEQA® (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC)

• Today's marketing authorization is based on recent results from the Phase III ARANOTE trial and broadens the indication profile of darolutamide in metastatic hormone-sensitive prostate cancer (mCSPC), enabling its use in combination with ADT, with or without chemotherapy (docetaxel)

MISSISSAUGA, ON, Aug. 21, 2025 /CNW/ - Bayer Inc. is pleased to announce that Health Canada has granted marketing authorization for its oral androgen receptor inhibitor (ARi) NUBEQA^® (darolutamide)¹ for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This marketing authorization is based on results from the pivotal² Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mCSPC.

With this additional marketing authorization, darolutamide plus ADT is the first and only ARi indicated in Canada for the treatment of adult patients with mCSPC, either with or without docetaxel. In addition, darolutamide is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

"This latest authorization reaffirms NUBEQA's role as a therapy for men with prostate cancer," said Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. "We extend our thanks to the scientists, doctors, patients, and their families for their contributions that allowed us to offer this new treatment option for metastatic castration-sensitive prostate cancer."

"Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with androgen-deprivation therapy," said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial. "Today's approval further expands options for how physicians can use Nubeqa in the treatment of mCSPC, giving them greater flexibility in choosing treatment plans for their patients."

In Canada, prostate cancer is the most commonly diagnosed cancer among men, with an incidence rate of 119.7 cases per 100,000 men annually.³ Among those who are diagnosed, there is a portion of patients who will present with metastatic castration-sensitive prostate cancer (mCSPC), which may occur either de novo (newly diagnosed with metastatic disease) or as metachronous (recurrent disease following treatment for localized prostate cancer). In Canada, approximately 8.6% of all new prostate cancer cases are diagnosed as de novo mCSPC.⁴ Prognosis varies by disease stage, and while overall survival for prostate cancer is high, the 5-year net survival rate for patients with stage IV metastatic prostate cancer is approximately 41%, highlighting the need for optimized treatment strategies in this population. ²

"Prostate cancer continues to have a significant impact on men and their families in Canada, with incidence and mortality rates that remain unacceptably high," said Dr. Stuart Edmonds, Executive Vice President for Mission, Research and Advocacy at the Canadian Cancer Society. "Bringing more treatments to patients faster offers new hope, greater choice, and the potential for improved outcomes."

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARANOTE Trial

The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mCSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is rPFS (radiographic progression-free survival), measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to metastatic castration-resistant prostate cancer, time to initiation of subsequent systemic anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial were presented at ESMO 2024 and published in The Journal of Clinical Oncology.

About Bayer 

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people, and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.ca.

References: 

Nubeqa® Canadian Product Monograph https://www.bayer.com/sites/default/files/2020-11/nubeqa-pm-en.pdf

Journal of Clinical Oncology: 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 

Canadian Cancer Statistics Advisory Committee. Canadian Cancer Statistics 2023. Toronto, Ontario: Canadian Cancer Society; 2023.

Canadian Cancer Society. Survival statistics for prostate cancer. 2021; https://cancer.ca/en/cancer-information/cancer-types/prostate/prognosis-and-survival/survival-statistics.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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SOURCE Bayer Inc.