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A “life-extending” drug for patients living with advanced prostate cancer has been recommended for use on the NHS in England and Wales by the National Institute for Health and Care Excellence (NICE).
In final draft guidance, published on 24 October 2025, NICE approved darolutamide (Nubeqa; Bayer) for adults with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT), which is a hormone therapy that lowers testosterone levels.
The combination treatment, which is taken as two tablets twice daily, alongside ADT, could benefit around 6,000 people in England, NICE said.
Darolutamide works by blocking the hormones fuelling cancer growth by starving prostate cancer cells of the testosterone needed to multiply and spread.
NICE estimates that around 55,000 people are diagnosed with prostate cancer each year in England.
Commenting on the recommendation, Diana Matthews, advanced oncology pharmacist and non-medical prescriber in urology at Velindre Cancer Centre at Velindre University NHS Trust in Cardiff, said: “We welcome the news within the uro-oncology community with great joy.
“Darolutamide presents as another choice of treatment within the same setting for this group of patients, allowing for a different type of discussion to take place in clinic, where we won’t focus solely on clinical outcomes but also continue to drive patient empowerment on their treatment choices,” she added.
“The toxicity profile from the ARANOTE trial seems more favourable, and there are also less drug–drug interactions, which becomes relevant in a group of patients that is very often already polymedicated.”
Clayton Wong, principal pharmacist in cancer services at Royal Free London NHS Trust, said: “It is positive news that NICE has recommended the use of darolutamide in the metastatic hormone-sensitive prostate cancer, despite multiple treatment options being already available. This gives clinicians and patients the options to choose the treatment that is best suited to the patients’ individual clinical needs.
“It is also reassuring that NICE and NHS England are still committing to making new drugs available to the public so long as they are clinically effective, good value and addressing an unmet need in our population.”
Helen Knight, director of medicines evaluation at NICE, commented: “I’m pleased we can recommend this new combination treatment, which provides another much-needed option for people with metastatic hormone-sensitive prostate cancer.
“Clinical trials show that adding darolutamide to standard ADT delivers better results than ADT alone, with evidence suggesting it is as effective as other combination treatments already recommended by NICE and available on the NHS.”
Other treatments available on the NHS for prostate cancer include chemotherapy, radiotherapy, hormone therapy, surgery, high-intensity focused ultrasound and cryotherapy.
