Thousands of men with advanced prostate cancer in England are to be offered a drug that can halve the risk of death.
In guidance published on Friday, the National Institute for Health and Care Excellence (Nice) gave the green light to darolutamide, which attacks the disease by starving cancer cells and has fewer side-effects than existing treatments.
At least 6,000 men a year with metastatic hormone-sensitive prostate cancer will get access to the novel treatment, also known as Nubeqa and made by Bayer, on the NHS.
Darolutamide, taken as two tablets twice daily, works by blocking hormones fuelling cancer growth. The treatment is delivered alongside androgen deprivation therapy (ADT), a hormone therapy that lowers testosterone levels.
Data show the treatment combination is better than using ADT alone and is as effective as other combination treatments, according to Nice.
Helen Knight, the 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.”
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.
Trials show adding darolutamide to standard ADT cuts the risk of death by 46% compared with ADT alone, with evidence suggesting it is as effective as other combination treatments already recommended by Nice and available on the NHS.
The charity Prostate Cancer UK said the new drug offered men a “gentler” treatment option with fewer side-effects compared with ADT in combination with other therapies. This could benefit older men or those who cannot be prescribed current treatments.
Amy Rylance, an assistant director of health improvement at Prostate Cancer UK, said: “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.
“While it’s just as effective as existing drugs, it has fewer side-effects. Our hope is that this will make it easier for more men to benefit from these treatments – because right now, too many men are missing out on the treatments that can extend their lives.
“It’s great that new drugs like this are being approved but this is only the first step – that’s why the government must ensure the new national cancer plan includes steps to make sure the right treatments reach the men who need them.”
Rylance said she had concerns that some men now eligible for the drug may still be unable to access it because of a “postcode lottery of care” in England.
She highlighted data from the recent national prostate cancer audit, which showed that less than half (47%) of men with advanced prostate cancer got the latest recommended treatments.
Peter Johnson, the 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.”
