Bayer's prostate cancer drug Nubeqa cleared for NHS use

Thousands of men living with advanced, hormone-sensitive prostate cancer (HSPC) in England and Wales will be able to access Bayer's Nubeqa, after it was recommended for NHS use by reimbursement authority NICE.

The new guidance covers the use of the testosterone-lowering drug in combination with androgen deprivation therapy (ADT), which patient advocacy group Prostate Cancer UK said has fewer side effects than ADT combined with other equivalent therapies.

The Nubeqa (darolutamide) regimen can be used to treat adult patients with advanced HSPC if docetaxel, a chemotherapy agent, is not suitable, according to NICE, which said NHS trusts should be able to offer the new treatment from today.

The ARANOTE trial showed that adding Nubeqa to standard ADT cut the risk of death or disease progression by 46% compared to ADT alone, with evidence suggesting it is as effective as other combination treatments – such as Johnson & Johnson's Erleada (apalutamide) and Astellas' Xtandi (enzalutamide) plus ADT – that are already recommended by NICE and available on the NHS.

NICE previously endorsed the use of Nubeqa/ADT in early-stage castration resistant prostate cancer (CRPC) patients at high risk of developing metastatic disease, and for use alongside docetaxel in advanced HSPC.

According to Bayer, it is now the only combination therapy reimbursed in England and Wales that can be used as a treatment option for mHSPC, with and without chemotherapy.

Prostate Cancer UK said Nubeqa will play an important role as a "gentler" option for men who are older or who cannot be prescribed existing treatments, such as docetaxel, enzalutamide, or apalutamide.

However, it pointed to recent data from the National Prostate Cancer Audit (NPCA) that showed that less than half (47%) of men with incurable prostate cancer receive the latest treatments – even if they have been recommended by NICE. Men who are Black, older, or living in areas of deprivation are even less likely to get new treatment options.

"Darolutamide is an effective treatment that could make a huge difference for men with incurable prostate cancer," said Amy Rylance, the charity's assistant director of health improvement. "But the reality is that too many men will still miss out on treatments that could extend their lives, simply because of where they live, their age, or their ethnicity."

Prostate Cancer UK has called on the government to ensure that the upcoming National Cancer Plan – due to be published later this year – will end those inequalities and ensure that NICE-approved treatments are delivered equitably and effectively across the country.