NICE backs new prostate cancer drug that halves death risk

Thousands of men across England are set to benefit from a newly approved, better-tolerated prostate cancer treatment. The National Institute for Health and Care Excellence (NICE) has recommended darolutamide (Nubeqa), a hormone-blocking drug, in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer (mHSPC) who are unsuitable for chemotherapy.

For an estimated 6,000 men each year, this marks a welcome shift in the balance between treatment effectiveness and tolerability, and a significant milestone in the ongoing fight against one of the UK’s most prevalent cancers.

In this blog, Dr Richard Dune explores how this latest NICE approval signals progress in prostate cancer care, balancing innovation, accessibility, and quality of life for patients across the NHS.

A major health challenge, and a matter of equity

Prostate cancer is now the most commonly diagnosed cancer in men in the UK, affecting around 55,000 men annually and claiming over 12,000 lives each year (Cancer Research UK, 2023). Globally, the disease causes more than 1.2 million new cases and around 350,000 deaths each year (Sung et al., 2021).

The disease mainly affects older men, particularly those aged 65–74, but the risk is not evenly distributed. Black men face roughly double the lifetime risk, around one in four, compared with one in eight for white men (Prostate Cancer UK, 2024). Genetics and environmental factors play a role, but inequities in diagnosis, awareness and access to treatment also contribute.

A 2023 analysis revealed a north–south divide in prostate-cancer diagnosis: men in some northern regions are almost three times more likely to be diagnosed after the cancer has spread compared with those in southern England (Prostate Cancer UK, 2023). Such disparities have real-world consequences, determining who receives early, curative treatment and who faces more complex, palliative pathways.

A gentler, equally effective option

NICE’s latest guidance, published on 24 October 2025, confirms that darolutamide plus ADT offers men who cannot tolerate chemotherapy an effective, lower-toxicity treatment option (NICE, 2025a; BMJ, 2025).

The BMJ reported that NICE’s final draft guidance found that darolutamide + ADT was as effective as apalutamide + ADT, an existing NICE-approved combination, but with fewer side effects and fewer drug interactions (BMJ, 2025). This is particularly important for older men who often take multiple medications, increasing their risk of adverse interactions.

The Guardian noted that clinical trials showed the new combination cut the risk of death by 46% compared with ADT alone, while matching the survival benefits of other advanced therapies already available on the NHS (The Guardian, 2025).

Helen Knight, director of medicines evaluation at NICE, welcomed the news, saying:

“We are determined to ensure that effective treatments such as darolutamide, which can help extend the length and quality of people’s lives, are made available fast to the people who need them.”

How the treatment works

Darolutamide, developed by Bayer, belongs to a class of drugs known as androgen-receptor inhibitors (ARIs). These drugs block testosterone’s ability to stimulate the growth of prostate cancer cells.

When combined with androgen deprivation therapy (ADT), the long-established hormone therapy that suppresses testosterone production, darolutamide creates a double blockade against the hormonal fuel that drives cancer growth.

Taken as two tablets twice daily, darolutamide + ADT can be prescribed in outpatient settings, allowing men to manage treatment primarily at home.

Clinical data from the ARANOTE trial and earlier studies demonstrated significant improvements in progression-free and overall survival, with a lower incidence of fatigue, cognitive side-effects and falls than other drugs in its class (Chi et al., 2024; Fizazi et al., 2022).

For older or frail men who cannot undergo chemotherapy, this combination provides an opportunity to extend survival without sacrificing quality of life.

The significance for patients and professionals

The NICE decision goes beyond a single medicine: it represents progress toward more personalised and equitable prostate-cancer care.

Chemotherapy remains effective but can be gruelling. Many men with advanced disease are managing multiple health conditions, such as diabetes, heart disease or chronic kidney disease, that make chemotherapy’s toxicity unmanageable. Darolutamide + ADT gives these men a clinically proven, well-tolerated alternative.

Amy Rylance, assistant director of health improvement at Prostate Cancer UK, hailed the development as “an important new treatment that gives thousands of men with incurable prostate cancer another effective option that could halve their risk of death.”

She added a note of caution, however, warning that “a postcode lottery of care” could prevent some men from benefiting. National audit data show that fewer than half (47%) of men with advanced prostate cancer currently receive the latest recommended treatments (Prostate Cancer UK, 2025).

Peter Johnson, NHS England’s national clinical director for cancer, echoed that message:

“This decision provides another welcome treatment option… giving clinicians and their patients more flexibility to choose the approach best suited to individual circumstances.”

Closing the equity gap

Even the best clinical advances can fall short if access remains unequal. NHS England data from 2018 to 2022 show that treatment intensification for mHSPC, combining ADT with newer ARIs, rose from 34% to 45%, but this still leaves most men on ADT alone (NHS England, 2024).

Those least likely to receive intensified therapy are older, Black, or living in deprived areas. That pattern is consistent with other long-term conditions and underscores the need for targeted public health and workforce interventions.

To ensure this new guidance delivers on its promise, local NHS systems and integrated care boards (ICBs) will need to:

• Update clinical pathways to include darolutamide + ADT for eligible patients

• Train multidisciplinary teams, including oncologists, urologists, pharmacists, and nurses, on eligibility, dosing, and patient counselling

• Monitor uptake and outcomes through dashboards, stratified by age, ethnicity and geography

• Address barriers to awareness among patients and primary-care professionals, particularly in underrepresented communities.

Implications for training, governance and compliance

For regulated health and social-care providers, the update has implications far beyond oncology. Compliance and training frameworks must reflect the latest NICE guidance, ensuring professionals are prepared to implement new pathways safely and equitably.

Learning management systems (LMS) can be leveraged to cascade updated content, such as:

• NICE TA 903 and 2025 darolutamide + ADT guidance;

• Management of hormone-sensitive and metastatic prostate cancer;

• Shared-decision-making principles;

• Patient communication and consent; and

• Monitoring and side-effect management.

CQC-regulated services should review their governance documentation, ensuring care plans, consent forms and audit templates are updated. Regular compliance audits will help identify disparities in offer and uptake, which is vital for meeting equality and quality standards.

What this means for patients

For men and their families, the impact could be profound. The combination of darolutamide + ADT offers:

• Improved survival compared with ADT alone

• Comparable effectiveness to other ARI-based regimens

• Fewer side effects, enhancing tolerance for older and frailer men

• Greater convenience, with oral dosing at home.

These benefits collectively support a better quality of life, potentially reducing hospital visits and freeing capacity within overstretched oncology services.

A step forward, but not the final destination

The NICE approval marks a significant milestone, but as campaigners and clinicians agree, it is only the first step. Real progress depends on ensuring that every eligible man, regardless of postcode or background, can access the treatment.

This will require joined-up efforts from NHS leaders, training providers, and digital-compliance systems to ensure equitable roll-out, continuous professional development, and robust monitoring of real-world outcomes.

For The Mandatory Training Group and health-education partners, this is an opportunity to lead by embedding the new NICE guidance into accredited training, statutory and mandatory modules, and professional development frameworks across oncology and primary care teams.

Looking ahead

Darolutamide’s approval alongside ADT signals the NHS’s growing commitment to faster, evidence-based access to new therapies. NICE achieved this through a cost-comparison appraisal, demonstrating that efficient evaluation can coexist with clinical rigour.

As Helen Knight of NICE put it:

“We are determined to ensure that effective treatments such as darolutamide… are made available fast to the people who need them.”

This message resonates beyond oncology. It speaks to the values of health-system transformation, governance, compliance, digital innovation, and equitable access that underpin every aspect of modern healthcare delivery.

Final reflection

For men with advanced prostate cancer, this decision is more than a new drug approval; it represents hope, a better-tolerated, evidence-based option that extends life without compromising dignity.

For healthcare leaders and compliance professionals, it underscores the importance of turning policy into practice, ensuring that research progress translates into measurable improvements in outcomes, access, and equity.

When policy, innovation and governance align, transformation becomes possible. And in this case, transformation could mean thousands more men living longer, better lives.

Stay informed  and join the conversation on prostate health and beyond

At The Mandatory Training Group, we’re committed to raising awareness of prostate cancer and other primary health conditions, while supporting health and social care professionals through continuous learning, digital compliance, and innovation.

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References

Wise, J. (2025) - Prostate cancer drug: NICE approves better-tolerated combination for advanced cases. 

Cancer Research UK (2025) - Prostate cancer statistics.

Saad, F. et al. (2024) - Darolutamide in combination with Androgen-Deprivation therapy in patients with Metastatic Hormone-Sensitive Prostate Cancer from the Phase III ARANOTE trial.

Smith, M.R. et al. (2022) - Darolutamide and survival in Metastatic, Hormone-Sensitive Prostate Cancer

NICE (2023) - Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. 

NICE (2025) - Up to 6,000 patients to benefit from NICE-approved life-extending prostate cancer drug. 

NHS England (2024) - Treatment intensification in metastatic hormone-sensitive prostate cancer in England: 2018–2022 trends. London: NHS England.

Eule, C.J. et al. (2024) - Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer: An Analysis of Real-World Practice Patterns from the CancerLinQ Database. 

Prostate Cancer UK (2023) - Huge north–south divide in prostate cancer diagnoses revealed.

Prostate Cancer UK (2024) - About prostate cancer and risk factors. 

Sung, H. et al. (2021) - Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.

Gregory, A. (2025) - Prostate cancer drug that can halve death risk to be offered to thousands in England.