An immunotherapy drug will be made available to some patients with advanced melanoma skin cancer on the NHS in England.
Pembrolizumab (Keytruda) will soon be an option for patients whose melanoma has spread to the lymph nodes and who have already had surgery. The drug works by boosting the immune system’s ability to kill cancer cells and will be given to help target any cancer cells left behind after surgery.
In a clinical trial involving over 1000 patients, 15 in 20 of those taking pembrolizumab were cancer free 12 months after treatment, compared to just over 12 in 20 of those taking a dummy drug. In data provided to NICE, the effects of pembrolizumab were maintained at 18 months.
But severe side effects, including type 1 diabetes and bowel inflammation, were more common in patients taking pembrolizumab. 15 in 100 patients taking the immunotherapy experienced severe side effects compared with 3 in 100 patients taking the dummy drug. One person died as a result of taking pembrolizumab, which caused muscle inflammation.
Speeding up access to new treatments
While an early glimpse of the clinical trial results looked promising, the long-term effects of the drug aren’t known, and the trial is still running. The National Institute of Health and Care Excellence (NICE) committee said in its NHS guidance there was also limited information on the overall survival benefits of the treatment.
Pembrolizumab will therefore be made available through the Cancer Drugs Fund while more data is collected on its effectiveness. The fund was redesigned in 2016 to speed up access to promising new treatments.
The therapy will be made available once it has been licensed for use in Europe, which should happen in early December 2018.
“The fact that this decision has come before the drug has even been licensed shows that NICE, NHS England and the drug company have worked together well to make sure patients will be able to access this treatment as quickly as possible,” said Gray.
NICE (2018) Pembrolizumab for adjuvant treatment of melanoma with high risk of recurrence – Final appraisal document