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)
• 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October 2025 – Bayer announces today that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of darolutamide in combination with ADT as an option for treating adult patients with mHSPC who are unsuitable for chemotherapy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 

Notes to Editors

About metastatic hormone-sensitive prostate cancer (mHSPC)

mHSPC is advanced cancer that has spread beyond the prostate to other parts of the body but still responds to treatment with hormone therapy.12 mHSPC precedes the development of metastatic castration-resistant prostate cancer (mCRPC),13 which no longer responds to treatment with hormone therapy. Despite treatment, most men with mHSPC will eventually progress to mCRPC,14 a condition with limited survival.

Prostate cancer accounts for nearly 28% of all new cancer diagnoses (2017 – 2019).4 In the UK, 1 in 8 men will be diagnosed with prostate cancer.15 The risk of developing prostate cancer is significantly higher in Black African males than in White or Asian males.4 1 in 4 Black men will get prostate cancer in their lifetime, and 1 in 12 Black men will die from prostate cancer.15

About the ARANOTE Trial

The ARANOTE trial is a randomised, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomised 2:1 to receive either 600mg of darolutamide twice daily or placebo in addition to ADT.16

The primary endpoint of this study was radiological progression-free survival (rPFS), measured as time from randomisation 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 CRPC (castration-resistant prostate cancer) event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.16

About prostate cancer at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men globally (based on data from 2020)17, the most common cancer in men in the UK, and a key area of focus for Bayer. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that could potentially extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities so that patients can live longer and better lives.

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.co.uk.

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.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

References:

1. National Institute for Health and Care Excellence (NICE). Final Draft Guidance. Darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer. Issue date: October 2025. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11557/documents

2. Saad, F et al. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. doi/10.1200/JCO September 2024. Available at: https://ascopubs.org/doi/10.1200/JCO-24-01798. Last accessed: October 2025. 

3. Technology Appraisal Guidance. TA903. National Institute for Health and Care Excellence. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. Available from: https://www.nice.org.uk/guidance/ta903. Last accessed: October 2025.

4. Cancer Research UK. Prostate cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer. Last accessed: October 2025.

5. Prostate Cancer UK. It’s a fact: prostate cancer now England’s most common cancer. Available at: https://prostatecanceruk.org/about-us/news-and-views/2025/01/most-common-cancer-england. Last accessed: October 2025.

6. National Prostate Cancer Audit. State of the Nation Report 2025. Available at: https://www.natcan.org.uk/reports/npca-state-of-the-nation-report-2025/. Last accessed: October 2025.

7. C. Oing & R. G. Bristow. Systemic treatment of metastatic hormone-sensitive prostate cancer - upfront triplet versus doublet combination therapy. ESMO. https://doi.org/10.1016/j.esmoop.2023.101194.

8. Z. Yue et al. The association between polypharmacy and health-related quality of life among older adults with prostate cancer. Journal of Geriatric Oncology. https://doi.org/10.1016/j.jgo.2024.101772

9. NUBEQA® (darolutamide) 300 mg film-coated tables Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11324 Last accessed: October 2025.

10. Morgans AK, Haresh KP, Jievaltas M, Olmos D, Shore ND, Vjaters E, Xing N, Mohamed AF, Littleton N, Srinivasan S, Verholen F, Saad F. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. J Clin Oncol. 2025;43(16_suppl):5004. Available at: https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5004.

11. Technology Appraisal Guidance. TA660. National Institute for Health and Care Excellence. Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer. Available from: https://www.nice.org.uk/guidance/ta660/chapter/2-Information-about-darolutamide. Last accessed: October 2025.

12. Cancer.Net. ASCO answers: Prostate Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf Last accessed: October 2025.

13. Cattrini et al. Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer. Cancers.2019 11(9), p.1355

14. Ritch, C. & Cookson, M. Recent trends in the management of advanced prostate cancer. F1000Res. 2018 Sep 21;7:F1000 Faculty Rev-1513.

15. Prostate Cancer UK. Prostate cancer statistics 2023. Available from: https://prostatecanceruk.org/for-health-professionals/data-and-evidence Last accessed: October 2025.

16. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Clinicaltrial.gov. Available at: https://www.clinicaltrials.gov/study/NCT04736199. Last accessed: October 2025.

17. Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834. Last accessed: October 2025. 

RP-NUB-GB-0814 / October 2025