NICE recommends Bayer’s Nubeqa® (darolutamide) plus androgen deprivation therapy as a treatment option for patients with hormone-sensitive metastatic prostate cancer

NICE recommends Bayer’s Nubeqa^® (darolutamide) plus androgen deprivation therapy as a treatment option for patients with hormone-sensitive metastatic prostate cancer

• Nubeqa^® (darolutamide) plus androgen deprivation therapy (ADT) is now available through NHS England and Wales as an option for treating adult patients with hormone-sensitive metastatic prostate cancer (mHSPC)¹
• The NICE recommendation is based on the pivotal Phase III ARANOTE trial, which confirmed the efficacy and tolerability profile of darolutamide plus ADT in mHSPC^1,2
• The new guidance builds on previous NICE recommendation for darolutamide and makes darolutamide plus ADT the only combination therapy reimbursed in England and Wales as a treatment option for mHSPC, with and without chemotherapy (docetaxel)^1,3

Reading, UK, 24^th October 2025 – Bayer announces today that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of darolutamide in combination with ADT as an option for treating adult patients with mHSPC who are unsuitable for chemotherapy (docetaxel).¹ The decision means eligible prostate cancer patients with mHSPC will now have access to darolutamide plus ADT through the NHS in England and Wales.

Prostate cancer remains a significant public health concern in the UK, with over 55,000 new cases diagnosed every year⁴, making it the most common cancer in men⁴ in England⁵. The 2025 National Prostate Cancer Audit (NPCA) report found that on average 12% of prostate cancer patients (1 in 8 men) in England had metastatic disease at diagnosis in 2022/2023,⁶ and those with mHSPC tend to have a poor prognosis.⁷ The highest prevalence of prostate cancer in the UK occurs in older men (aged 75 – 79)⁵, who are more likely to experience considerable comorbidities and require polypharmacy.⁸ Prostate cancer is also the second leading cause of cancer-related deaths in the country with around 12,000 deaths every year – that’s 33 men every day (2017 – 2019).⁵

"Despite advances in prostate cancer care, there is still a need to expand treatment options for men with advanced disease, especially those facing symptoms and side effects that impact their daily lives. Our aim is to enhance their quality of life while improving survival, which means more quality time with loved ones. Treatment should be personalised to each patient’s unique situation, including their age, health issues, and preferences," said Professor Alison Birtle, Consultant Clinical Oncologist at the Rosemere Cancer Centre, Lancashire Teaching Hospitals. "The addition of darolutamide plus ADT to the treatment options gives UK physicians greater flexibility to tailor treatments for better long-term outcomes and maintaining patient quality of life."

Today’s decision by NICE follows the recent authorisation of the indication in June by the Medicines and Healthcare products Regulatory Agency (MHRA)⁹ and is based on positive results from the pivotal Phase III ARANOTE trial, evaluating the efficacy and tolerability profile of darolutamide plus ADT in patients with mHSPC.² The trial showed that darolutamide plus ADT significantly improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 46% (absolute risk at 2 years: 18.2%; HR 0.54; 95% CI 0.41–0.71; P<0.0001), compared to placebo plus ADT.² The rPFS rates at 24 months were 70.3% in the darolutamide group and 52.1% in the placebo group.⁹

The trial also showed that darolutamide plus ADT had a similar overall incidence of adverse events (91% vs 90%) and lower discontinuation rates due to adverse events vs placebo plus ADT (6.1% vs 9.0%), meaning patients stay on treatment for longer.² Health-related quality of life was measured using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and darolutamide plus ADT extended time to deterioration in FACT-P total score (overall well-being) by 5.1 months vs placebo plus ADT (median 16.6 vs 11.5 months; HR 0.76, 95% CI 0.61–0.93).¹⁰

Oliver Kemp MBE, CEO of Prostate Cancer Research said: “We are pleased that eligible men with advanced prostate cancer in England and Wales can now benefit from this treatment option. Advanced prostate cancer presents profound challenges that significantly affect not only patients but also their families, underscoring the need for ongoing research and the development of new treatment options. It is vital that we continue to raise awareness and advocate for better access to timely diagnoses, effective treatments, and comprehensive support services that patients and their families need to navigate this challenging journey.”

"We are delighted that NICE has given the green light for darolutamide for this indication, marking a significant milestone in our mission to bring new therapeutic options to patients with advanced prostate cancer," said Tomer Feffer, CEO of Bayer UK & Ireland, Head of Region Northeast-Central Europe. "We will continue to work with healthcare professionals to identify the groups of patients who will most benefit from this option, making it available to as many eligible patients as possible. Given the rising incidence of prostate cancer in the UK due to an aging population and improved diagnostics, we are fully committed to supporting the NHS in tackling the challenges within the treatment pathway, such as health inequalities, to ensure that patients receive the most effective treatment tailored to their disease at the time of diagnosis."

In the UK, darolutamide combined with ADT was recommended by NICE (TA660) as a treatment option for patients with non-metastatic castration resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, in November 2020.¹¹ In June 2023, NICE published guidance (TA903) recommending darolutamide plus ADT with chemotherapy (docetaxel) as a treatment option for patients with mHSPC.³ 

ENDS

Bayer media contact:

Veronica Yao, +44 (0)787 048 5926

Email: veronica.yao@bayer.com