The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly 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 mHSPC.

Darolutamide, under the brand name Nubeqa, is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease.

“Today’s approval of darolutamide plus ADT means that it can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients and improve clinical outcomes for men with mHSPC,” 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.

“Results from the ARANOTE trial demonstrate that darolutamide plus ADT delays disease progression and extends survival, and just as importantly, due to its high tolerability, enables patients to maintain their daily living with minimal disruption.”

Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.

“The third European approval of darolutamide represents a significant step forward for men with advanced prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Darolutamide is the first androgen receptor inhibitor to show clinically meaningful health-related quality of life benefits, offering patients an effective and well tolerated treatment. Backed by compelling clinical data from the ARANOTE, ARASENS, and ARAMIS trials, we believe darolutamide has the potential to become a leading therapy across various stages of prostate cancer. We are committed to ensuring its broad availability to benefit as many eligible patients as possible.”

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