New Oral Treatment Option Approved for Men with Advanced Prostate Cancer


NICE Endorses Oral Alternative to Chemo in Prostate Cancer

Good news for patients unable to tolerate chemotherapy

Men with metastatic hormone-sensitive prostate cancer who cannot receive or tolerate chemotherapy now have a new treatment option available through the NHS. The National Institute for Health and Care Excellence (NICE) has recommended darolutamide (brand name Nubeqa) in combination with androgen deprivation therapy (ADT) for approximately 6,000 patients in England and Wales.

What is Darolutamide and How Does It Work?

Darolutamide is an oral medication that works by blocking the hormones that fuel prostate cancer growth. Specifically, it prevents prostate cancer cells from accessing the testosterone they need to multiply and spread throughout the body.

The treatment is taken as two tablets twice daily alongside standard ADT. This oral format offers a significant advantage for patients who cannot tolerate intravenous chemotherapy like docetaxel or who are unable to receive other androgen-receptor inhibitors.

The Evidence Behind the Decision

NICE's recommendation was based on strong clinical evidence from the ARASENS trial, a major phase 3 study involving 1,306 patients. The trial demonstrated that adding darolutamide to ADT and docetaxel significantly improved overall survival, reducing the risk of death by 32% compared to ADT and docetaxel alone. Patients also experienced better progression-free survival, meaning more time before the disease advanced to castration-resistant prostate cancer.

Additional analysis by NICE compared darolutamide with other similar treatments, including apalutamide, enzalutamide, and abiraterone. The review of multiple clinical trials (TITAN, ARCHES, LATITUDE, and STAMPEDE) suggested that these androgen-receptor pathway inhibitors provide comparable survival benefits when combined with ADT.

What This Means for Patients

Peter Johnson, national clinical director for cancer at NHS England, welcomed the approval, stating it will give clinicians and patients "more flexibility to choose the approach best suited to individual circumstances and clinical needs."

The guidance was finalized 5 weeks ahead of the standard review timeline, demonstrating NICE's commitment to getting effective prostate cancer treatments to patients as quickly as possible.

Cost and Availability

While the list price for darolutamide is £4,040 for a 28-day supply, the manufacturer (Bayer) has agreed to a confidential discount with the NHS. NICE determined that darolutamide plus ADT offers similar or lower overall costs compared to apalutamide plus ADT.

Healthcare providers are required to use the most cost-effective suitable treatment option when choosing between different androgen-receptor inhibitors, considering factors like administration costs, dosages, and available discounts.

NHS England and integrated care boards must provide funding within 30 days of the guidance's final publication, meaning this treatment should be available through routine commissioning soon.

Impact on American Clinical Practice

While this NICE approval specifically affects patients in England and Wales, it has important implications for American prostate cancer patients and clinical practice in the United States.

Current US Approval Status

Darolutamide (Nubeqa) is already FDA-approved in the United States, though initially with different indications. The FDA first approved darolutamide in 2019 for non-metastatic castration-resistant prostate cancer. In 2022, following the ARASENS trial results, the FDA expanded approval to include darolutamide in combination with docetaxel and ADT for metastatic hormone-sensitive prostate cancer.

Key Differences in Practice

The NICE approval is notable because it specifically endorses darolutamide plus ADT without docetaxel for patients who cannot tolerate chemotherapy. This represents a more flexible treatment approach than the current FDA label, which emphasizes the triple combination (darolutamide, docetaxel, and ADT).

However, American oncologists often prescribe treatments "off-label" based on clinical evidence and patient needs. The NICE decision, backed by comprehensive analysis comparing darolutamide to other androgen-receptor inhibitors, may influence US prescribing patterns for chemo-ineligible patients.

Insurance and Access Considerations

In the US healthcare system, insurance coverage remains a critical factor. Most major insurers cover darolutamide for FDA-approved indications, but coverage for the doublet regimen (darolutamide plus ADT without chemotherapy) in chemo-ineligible patients may vary by plan. The NICE cost-effectiveness analysis showing comparable or lower costs versus apalutamide could support insurance coverage decisions in the US.

American patients should discuss with their oncologists whether darolutamide plus ADT might be appropriate for their situation, and work with their insurance providers to understand coverage options.

Clinical Guidelines

Major US clinical guideline organizations, including the National Comprehensive Cancer Network (NCCN), regularly update their prostate cancer treatment recommendations based on global evidence. The NICE endorsement, combined with the ARASENS trial data and real-world evidence accumulating in the UK, may influence future NCCN guideline updates.

What American Patients Should Know

If you're an American patient with metastatic hormone-sensitive prostate cancer who cannot tolerate docetaxel or other standard treatments, darolutamide may be an option worth discussing with your oncology team. Key questions to ask include:

  • Is darolutamide appropriate for my specific disease characteristics?
  • How does it compare to other androgen-receptor inhibitors I might be able to take?
  • Will my insurance cover this treatment for my indication?
  • What are the potential side effects and how do they compare to alternatives?

The expanding body of international evidence and regulatory approvals continues to provide more options for prostate cancer patients on both sides of the Atlantic.

Looking Ahead

This approval represents an important step forward for men with metastatic hormone-sensitive prostate cancer, particularly those who have limited treatment options due to inability to tolerate chemotherapy. The oral format and proven effectiveness make darolutamide a valuable addition to the treatment landscape.

If you or a loved one might benefit from this treatment, speak with your oncologist about whether darolutamide plus ADT could be appropriate for your individual situation.

Sources

  1. Das, J. (2025). NICE Endorses Oral Alternative to Chemo in Prostate Cancer. Medscape Medical News. Available at: https://www.medscape.com/viewarticle/nice-endorses-oral-alternative-chemo-prostate-cancer-2025a1000gk9

  2. National Institute for Health and Care Excellence. (2025). Darolutamide with androgen deprivion therapy for treating metastatic hormone-sensitive prostate cancer [TA1054]. NICE Technology Appraisal Guidance. Available at: https://www.nice.org.uk/guidance/ta1054

  3. Smith, M.R., Hussain, M., Saad, F., et al. (2022). Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. New England Journal of Medicine, 386(12), 1132-1142. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2119115

  4. U.S. Food and Drug Administration. (2022). FDA approves darolutamide for metastatic hormone-sensitive prostate cancer. FDA Drug Approvals and Databases. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/

  5. National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

This article is for informational purposes only and should not replace professional medical advice. Always consult with your healthcare team about treatment decisions.

 

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