MSD’s Keytruda has become the only immunotherapy to be funded by the NHS for the treatment of bladder cancer, following a final green light from cost regulators.

The National Institute for Care and Health Excellence is endorsing use of the drug within the cancer drugs fund (CDF) for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable.

The guideline stipulates that Keytruda (pembrolizumab) should be stopped at two years of uninterrupted treatment or earlier in the event of disease progression.

The decision rides on the back of data from the KEYNOTE-045 trial, which showed that the drug extended overall survival by nearly three months more than chemotherapy (median overall survival of 10.3 months versus 7.4 months).

Andrew Winterbottom, founder and chief executive of Fight Bladder Cancer, said the organisation is “absolutely delighted” with the move.

“A cisplatin-containing chemotherapy is usually the first line of treatment for people with late stage bladder cancer, but many patients may not be suitable due to underlying clinical parameters. If people can’t tolerate it, there aren’t many options left. It is very exciting to see breakthroughs like this, where new treatments are likely to offer meaningful objective response for a number of patients receiving treatment and it is generally well tolerated - a major change in clinical practice.”

Over 10,000 people a year are diagnosed with bladder cancer in the UK and over 9,000 with urothelial cancer; around 540 of whom could now benefit from treatment with Keytruda.