NICE approves new immunotherapy drug for advanced melanoma

Cancer Research UK
A melanoma cell. Credit: Dr Erik Sahai

A new immunotherapy drug has been approved for NHS patients in England whose melanoma has stopped responding to previous treatments.

National Institute of Health and Care Excellence (NICE) made the decision after the drug's manufacturers struck a deal with the NHS over price.

Pembrolizumab, marketed as Keytruda, is one of a new generation of cancer drugs called checkpoint inhibitors, which work by 'unmasking' cancer cells and allowing the immune system to target them.

What are 'checkpoint' immunotherapy drugs?

Although not all patients respond, the drug can evoke significant responses in those that do.

Earlier this year, results of an international trial showed that, for some patients, the drug worked better than chemotherapy, and caused fewer serious side-effects. 

Today's decision means the drug will be available to patients with advanced melanoma who have already been treated with a checkpoint immunotherapy drug called ipilimumab, and - if suitable - with drugs targeted to specific DNA faults in their tumour.

Professor Peter Johnson, Cancer Research UK’s chief clinician, said pembrolizumab was 'a great example' of the progress in immune treatments for cancer.

"Pembrolizumab provides another option for patients with skin cancer which has spread around the body after they’ve tried other drugs.

"We’re pleased that NICE have acted quickly to make the drug available on the NHS in England and Wales," he added.

In March this year the drug was one of the first drugs to be made available under the Government's Early Access to Medicines Scheme (EAMS), which allows pharmaceutical companies to provide and pay for promising drugs to be provided on the NHS before they have been formally licensed for sale.

But the drug was licensed in Europe in July, meaning its manufacturers - Merck, Sharp & Dohme - could no longer provide it under the scheme.

Professor Carole Longson, Director of NICE's Health Technology Evaluation Centre said: “We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final draft guidance.  I am sure this will be welcome news to patients and healthcare professionals alike.”

Today’s decision applies to England only, but the Welsh Government tends to follow its decisions, and Northern Ireland’s Government should now determine whether the guidance will be applied there.

The Scottish Medicines Consortium, which covers treatments for Scotland, is due to publish advice on pembrolizumab in November. 

NICE said it was also in the process of looking at whether the drug could be made available to melanoma patients at an earlier point in their treatment. A decision that is expected early next year.