A new treatment hailed as ‘one of the most significant advances in decades for people with bladder cancer’ has been approved for NHS use in final draft guidance.
Around 1,250 patients a year in England could now be offered enfortumab vedotin with pembrolizumab, which has been shown to dramatically improve survival and remission rates.
It will be available for use in treating patients with untreated unresectable or metastatic urothelial cancer when platinum-based chemotherapy is suitable.
Clinical trials found that patients with advanced bladder cancer lived up to twice as long when treated with the combination therapy compared with standard chemotherapy.
For the 886 patients who participated in the trial, average survival increased from around 1.5 years with platinum-based chemotherapy to more than 2.5 years for patients treated using enfortumab vedotin with pembrolizumab.
The new treatment also kept the cancer at bay for longer, extending remission from just over six months to around 18 months.
Almost 30% of patients had no detectable cancer following treatment, compared with 12.5% in the chemotherapy group. Patients also experienced fewer harmful side effects because of the targeted approach of the drugs.
Hopeful bladder cancer advancement
The availability of enfortumab vedotin with pembrolizumab follows commercial agreements between NHS England and manufacturers Astellas Pharma and MSD UK, enabling the National Institute for Health and Care Excellence (NICE) to recommend it as cost-effective.
The combination treatment works by using a two-pronged attack. Enfortumab vedotin targets cancer cells and kills them, while pembrolizumab helps the immune system recognise and fight the remaining cancer cells.
The treatment is delivered by IV infusion to patients whose bladder cancer has spread or cannot be surgically removed.
More than 10,000 people are diagnosed with bladder cancer each year in the UK, and it can be challenging to treat. In its early stages, bladder cancer can be asymptomatic and, once it spreads beyond the bladder, it can be aggressive and resistant to chemotherapy, with an average life expectancy of just over a year.
Commenting on the NICE recommendation, Professor Peter Johnson, NHS England’s national clinical director for cancer, said: ‘This is one of the most hopeful advances in decades for people with bladder cancer who will now be offered a treatment that can almost double their chances of survival, helping thousands to live longer and giving them more precious moments with their loved ones.’
Final guidance is expected to be published on 11 September 2025.
A version of this article was originally published by our sister publication Healthcare Leader.
