The UK National Institute for Health and Care Excellence (NICE) has recommended the use of Keytruda (pembrolizumab) within the Cancer Drugs Fund for the treatment of bladder cancer.

Keytruda has been recommended as an option for treating locally advanced or metastatic urothelial cancer in adults who have had platinum-containing chemotherapy.

However, the recommendation applies only if pembrolizumab is stopped at two years of uninterrupted treatment or earlier in the event of disease progression, and the conditions in the managed access agreement are followed.

The recommendation is based on data that suggests the drug is more effective in improving overall survival than existing treatments, and meets NICE’s cost-effectivity guidelines.

In the recommendation document, NICE said: “Treatment for previously treated locally advanced or metastatic urothelial carcinoma is docetaxel or paclitaxel. Clinical trial evidence shows that pembrolizumab significantly improves overall survival compared with these drugs. Pembrolizumab meets NICE’s criteria to be considered a life-extending treatment at the end of life.

“Pembrolizumab has plausible potential to be cost-effective. Further data collection would reduce the uncertainty around overall survival and continued treatment effect. Therefore pembrolizumab can be recommended for use in the Cancer Drugs Fund.”

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The drug became the first immunotherapy to be recommended for NHS use for urothelial cancer last month. It is also used to treat non-smallcell lung cancer (NSCLC), melanoma skin cancer and Hodgkin lymphoma.

The FDA has granted Priority Review to Keytruda in combination with pemetrexed and platinum as a first-line treatment of metastatic nonsquamous NSCLC.

A type II variation of the drug is currently being reviewed as part of the European Medical Agency’s (EMA) centralised review process. Merck previously withdrew its marketing application to the EMA for Keytruda as a first-line treatment for NSCLC in October 2017.

In a recent study, the drug was shown to prolonged recurrence-free survival in patients with high-risk stage III melanoma.

Keytruda has received significant attention in recent years, with some experts predicting that the immunotherapy drug could replace chemotherapy as a first-line treatment for some cancers. Immunotherapy works by helping the immune system recognise and attack cancer cells, and has shown promise in reducing the chance of cancer returning after surgery.

Bladder cancer is the 10th most common cancer in the UK, accounting for 3% of all new cancer cases.  There are around 10,300 new bladder cancer cases in the UK every year.