The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Bayer’s Nubeqa (darolutamide), in combination with androgen deprivation therapy (ADT), as a treatment option for adult patients with hormone-sensitive metastatic prostate cancer (mHSPC) who are unsuitable for chemotherapy.
This recommendation builds on NICE’s previous approvals of Nubeqa, making the therapy the only reimbursed option in the UK for men with mHSPC—both with and without chemotherapy (docetaxel).
Nubeqa is a top-selling drug for Bayer. Last year, it generated €1.5 billion ($1.75 billion) in sales, marking a 78% increase from the previous year.
“This decision expands treatment options for men with advanced disease, helping clinicians tailor care to individual needs,” said Professor Alison Birtle, Consultant Clinical Oncologist at the Rosemere Cancer Centre, Lancashire Teaching Hospitals in a press release. “Darolutamide plus ADT provides flexibility to balance survival benefits with quality of life.”
Clinical Evidence
UK NICE’s guidance is based on positive results from the randomized, double-blind, placebo-controlled Phase III ARANOTE trial (NCT04736199). The study enrolled 699 patients and evaluated Nubeqa plus ADT in patients with mHSPC. Results showed a 46% reduction in the risk of radiological progression or death compared with placebo plus ADT.
After 24 months, radiological progression-free survival (rPFS) rates were 70.3% in the darolutamide group versus 52.1% in the placebo group.
Nubeqa also demonstrated a favorable safety profile, with similar overall adverse event rates (91% vs 90%) and fewer treatment discontinuations (6.1% vs 9.0%). Patients on darolutamide experienced an improvement in quality of life, with a median 5.1-month delay in deterioration of overall well-being scores compared with placebo.
Prostate cancer is the most common cancer among men in England, with over 55,000 new diagnoses each year and approximately 12,000 deaths annually. The 2025 National Prostate Cancer Audit reported that around one in eight men were diagnosed with metastatic disease between 2022 and 2023. Older men, particularly those aged 75–79, remain at highest risk, often with additional health complications that complicate treatment.
Tomer Feffer, CEO of Bayer UK & Ireland, hailed the approval as “a milestone in improving outcomes for men with advanced prostate cancer.” He added that Bayer will work closely with healthcare professionals to ensure eligible patients benefit from the therapy.
“With an aging population and rising incidence of prostate cancer, this decision supports the NHS in addressing treatment challenges and health inequalities,” Feffer said.
In July, Bayer also received a label expansion for another of its high-grossing drugs, Kerendia (finerenone). Following the US Food and Drug Administration (FDA)’s approval, Kerendia is approved for treating chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and for heart failure and left ventricular ejection fraction (LVEF) of 40% or higher.
