EMA Committee recommends marketing nod for Bayer advanced prostate cancer drug darolutamide
Berlin: Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorization in the European Union (EU), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
CHMP recommendation 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.
“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,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “European regulatory approval will mean that darolutamide plus ADT can be used with or without chemotherapy, expanding treatment options that would enable physicians to better meet the individual needs of patients living with mHSPC.”
“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,” 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.
A final decision on marketing authorization from the European Commission is anticipated in the coming months. The U.S. Food and Drug Administration (FDA) recently approved darolutamide in combination with ADT for mHSPC in June 2025, making it the US approved ARi for the treatment of patients with mHSPC, in combination with ADT, with or without chemotherapy.
Darolutamide, under the brand name Nubeqa, is 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.
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.
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were similar to the respective comparator arm. With this tolerability profile and limited risk of interactions with other medications, Nubeqa offers an advancement in treatment management for physicians and patients.
A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy.
Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival.
