NICE approves Merck’s Keytruda for advanced skin cancer following ipilimumab treatment
pharmafile | October 7, 2015 | News story | Research and Development | Merck, NHS, NICE, keytruda, skin cancer
The National Institute for Health and Care Excellence (NICE) has approved Merck’s Keytruda (pembrolizumab) for treating advanced skin cancer after treatment with ipilimumab and recommended that it is made available on the NHS.
Keytruda already received marketing authorisation in the UK as monotherapy ‘for the treatment of advanced (unresectable or metastatic) melanoma in adults’. The new appraisal looked specifically at the use of pembrolizumab in people who had already been treated with Bristol-Myers Squibb’s Yervoy ipilimumab.
NICE recommends that the drug is made available on the health service as a treatment for some patients with advanced melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (where the cancer has spread to other parts of the body).
Pembrolizumab, an immunotherapy, was the first drug to be approved through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme (EAMS), which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
Melanoma- the most common form of skin cancer- accounts for more cases than all other forms of the disease combined. More than 13,000 people were diagnosed with melanoma in the UK in 2011.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says: “We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final guidance. There were over 13,000 people diagnosed with malignant melanoma in the UK in 2011, and melanoma accounts for more deaths than all other skin cancers combinedi. This will be welcome news to patients and healthcare professionals alike.”
Life Sciences Minister, George Freeman MP, comments: “This is good news for the thousands of patients diagnosed with malignant melanoma every year, who can now be treated with this life-enhancing medicine.
“This has been a triumph for early access, but this Government wants to go further, which is why we set up the independent Accelerated Access Review which is looking at how we can reduce the time, cost, and risk of drug development, develop a new range of flexible reimbursement models and look at barriers to roll-out of adoption across the NHS.”
This latest approval for Keytruda comes after the drug was given the green light for advanced NSC lung cancer in the US earlier this week.
Joel Levy
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