New Prostate Cancer Drug Set to Halve Death Risk in England

Published: 24 October 2025. The English Chronicle Desk. The English Chronicle Online.

Thousands of men in England diagnosed with advanced prostate cancer will soon have access to a groundbreaking treatment shown to significantly reduce the risk of death. The National Institute for Health and Care Excellence (NICE) has approved darolutamide, also known commercially as Nubeqa, as part of a combination therapy for men with metastatic hormone-sensitive prostate cancer. The treatment is expected to benefit at least 6,000 patients annually on the NHS.

Darolutamide, manufactured by Bayer, is taken orally in the form of two tablets twice daily and works by blocking hormones that fuel cancer growth. It is used alongside androgen deprivation therapy (ADT), which lowers testosterone levels to slow cancer progression. Evidence from clinical trials demonstrates that combining darolutamide with ADT reduces the risk of death by nearly half compared to ADT alone, offering patients a more effective and tolerable treatment option.

Helen Knight, director of medicines evaluation at NICE, emphasised the importance of expanding treatment choices for patients facing this aggressive form of cancer. “We are pleased to recommend this new combination therapy, which provides another much-needed option for people with metastatic hormone-sensitive prostate cancer,” she said. “Our goal is to ensure that effective treatments such as darolutamide, which can extend both the length and quality of life, are made available quickly to those who need them.”

Metastatic hormone-sensitive prostate cancer is diagnosed when the disease has spread to other parts of the body, making treatment decisions more urgent and complex. Historically, standard care has involved ADT alone or in combination with other drugs, but the addition of darolutamide has been shown to offer comparable benefits to other existing combination therapies while producing fewer side effects.

Prostate Cancer UK hailed the approval as a breakthrough for patients seeking gentler yet effective treatment options. Amy Rylance, assistant director of health improvement at the charity, highlighted the benefits of darolutamide for older patients or those who may be unable to tolerate other treatments. “Darolutamide is an important new treatment that gives thousands of men with incurable prostate cancer another effective option that could halve their risk of death,” Rylance said. “It is just as effective as existing drugs but comes with fewer side effects, making it easier for more men to benefit.”

Despite the approval, concerns remain about accessibility due to regional disparities in healthcare provision across England. Rylance noted that a “postcode lottery of care” could mean some patients eligible for darolutamide may still struggle to receive it. She cited the recent national prostate cancer audit, which found that fewer than half of men with advanced prostate cancer had received the latest recommended treatments, underlining the need for consistent and equitable delivery of care nationwide.

Peter Johnson, clinical director for cancer at NHS England, welcomed the NICE decision, emphasising its potential to improve patient outcomes. “This decision provides another welcome treatment option for patients living with an advanced and aggressive form of prostate cancer,” he said. “With several proven therapies already available on the NHS, this approval gives clinicians and their patients more flexibility to choose the approach best suited to individual circumstances and clinical needs.”

Darolutamide’s mechanism of action represents a significant advance in prostate cancer therapy. By targeting androgen receptors, the drug effectively halts the signals that drive cancer cell growth. Its improved safety profile compared to other combination therapies means fewer adverse effects, making it a practical option for patients who may have previously been unable to tolerate intensive treatments.

Clinical studies indicate that darolutamide combined with ADT not only extends survival but also improves quality of life, reducing symptoms and the burden of side effects commonly associated with conventional therapies. This is particularly important for patients managing metastatic disease, where maintaining independence and daily functioning is a key consideration in treatment decisions.

The NICE approval aligns with broader national efforts to enhance access to life-extending cancer therapies. Recent years have seen increased focus on reducing waiting times for new treatments, improving early diagnosis, and ensuring that innovative therapies are delivered efficiently across the NHS. However, experts warn that sustained government support and strategic planning will be essential to prevent inequalities in treatment access from undermining the benefits of darolutamide.

Prostate Cancer UK continues to advocate for the integration of darolutamide into routine clinical practice while calling for measures to monitor and address regional variations in care. The charity urges policymakers to incorporate the new drug into the national cancer plan, ensuring that all eligible patients can access it without delay. “It’s great that new drugs like this are being approved, but this is only the first step,” Rylance said. “The government must ensure the national cancer plan includes steps to make sure the right treatments reach the men who need them.”

As awareness of darolutamide grows among clinicians and patients, education about its benefits and administration will be critical. NHS trusts will need to coordinate implementation strategies, train healthcare providers, and ensure that supply chains are robust to meet anticipated demand. These measures will be vital to maximise the impact of the drug on public health outcomes.

For men living with metastatic hormone-sensitive prostate cancer, darolutamide represents more than a treatment—it offers hope. With survival rates historically limited for advanced disease, the approval of a drug capable of halving mortality risk marks a significant milestone in cancer care. The ability to combine efficacy with improved tolerability positions darolutamide as a transformative option for thousands of men across England.

The wider implications of the approval also extend to the research community. Positive outcomes from darolutamide trials may encourage further investigation into similar targeted therapies, driving innovation and improving future treatment landscapes. Researchers and clinicians will be closely monitoring patient responses, long-term survival rates, and quality-of-life indicators as darolutamide becomes part of routine care.

In conclusion, the NICE approval of darolutamide represents a pivotal advancement in the management of advanced prostate cancer in England. By combining proven efficacy with a reduced side-effect profile, the treatment provides patients with a more tolerable and potentially life-saving option. Continued government support, equitable access, and effective implementation will be crucial in ensuring that the promise of darolutamide is realised across the country.