A male cancer patient discussing treatment with a healthcare professional

Darolutamide, also known as Nubeqa and made by Bayer, is recommended in final draft guidance to treat adults with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT), a hormone therapy which lowers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. 

It is estimated that around 55,000 people a year are diagnosed with prostate cancer in England. It is estimated that up to 6,000 people in England will be eligible for this new combination treatment, which is available from today in the NHS. 

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.

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. 

NICE used a cost comparison approach, where to get a positive recommendation, the company needed to demonstrate the costs for darolutamide plus ADT are similar to or lower than those for apalutamide plus ADT, which is recommended by NICE for this population and is already in use in the NHS. 

As a result, this final draft guidance was available five weeks faster than would have been the case under its standard process.  

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.

The company has a confidential commercial arrangement in place which makes darolutamide available to the NHS with a discount. 

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