The National Institute for Health and Care Excellence (NICE) has recommended pembrolizumab (Keytruda) as a treatment option for locally advanced or metastatic urothelial carcinoma which has been previously treated.
Pembrolizumab is recommended for the treatment of adults with locally advanced or metastatic urothelial carcinoma who have been treated with platinum-containing chemotherapy earlier. Pembrolizumab should be discontinued at 2 years of uninterrupted therapy or earlier if disease progression is evident.
The recommended dose for pembrolizumab is 200 mg administered intravenously every 3 weeks until the disease progresses, or undesirable toxicity is observed.
Evidence has shown significant improvement in OS with pembrolizumab compared with docetaxel or paclitaxel. It also fulfils NICE's criteria for life-extending end-of-life treatment. According to the appraisal committee, pembrolizumab has a plausible potential to be cost-effective. It will continue to be recommended within the Cancer Drugs Fund until enhanced data regarding OS and continued treatment effect become available.
The drug has been approved for use within the Cancer Drugs Fund and is to be used only when the conditions in the managed access agreement are followed. The recommendation should not affect patients whose treatment with the drug was started before publication of the guidance.
