The National Institute for Health and Care Excellence (NICE) has recommended Darolutamide, also known as Nubeqa, in final draft guidance to treat adults with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT), a hormone therapy which lowers testosterone levels.

Taken as two tablets twice daily alongside hormone treatment, Darolutamide blocks the hormones fuelling cancer growth by starving prostate cancer cells of the testosterone they need to multiply and spread.

Around 55,000 people a year are diagnosed with prostate cancer in England, and it is estimated that up to 6,000 people in England will be eligible for this new combination treatment, which is now available on the NHS.

For those with metastatic hormone-sensitive prostate cancer – where the disease has spread to other parts of the body – treatment options typically involve ADT, either on its own or combined with other drugs.

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.
As a result, this final draft guidance was available five weeks faster than would have been the case under its standard process.

Helen Knight, director of medicines evaluation at NICE, said: “I’m pleased we can recommend this new combination treatment which provides another much-needed option for people with metastatic hormone-sensitive prostate cancer. 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.”

Peter Johnson, national clinical director for cancer at NHS England, said: “This decision provides another welcome treatment option for patients living with an advanced and aggressive form of prostate cancer. 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.”