UK drug watchdog NICE has chosen to issue final guidance recommending the use of MSD’s Keytruda (pembrolizumab) on the NHS for the treatment of previously untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adult patients.

The decision means that the drug is the first immunotherapy to prove its cost-effectiveness by sufficiently backing up its efficacy and to be recommended for baseline commissioning after following its exit from the Cancer Drugs Fund (CDF).

Specifically, NICE has recommended Keytruda as an option in NSCLC tumours which express PD-L1 with at least a 50% tumour proportion score, and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations, only if use of the drug is stopped after two years of uninterrupted treatment, or earlier in the event of disease progression.

The decision was based on data which demonstrated that Keytruda provided almost 16 months of overall survival benefit compared to chemotherapy alone, while median overall survival stood at 30 months compared to 14.2 months for chemo. Adverse reactions associated with the drug’s use were of grade 1 or 2 severity, with the most serious reactions being immune or infusion-related.

"It is so exciting to see the first immuno-oncology treatment for lung cancer leaving the redesigned CDF for routine funding on the NHS. This is a landmark decision for lung cancer patients, who can now have complete confidence in ongoing access to pembrolizumab," remarked Gary Middleton, Professor of Medical Oncology at the University of Birmingham. "Lung cancer is such a tough disease but treatments like immunotherapies that harness the patient’s own immune system to fight their cancer have transformed the way we think about the disease and more importantly treat it. These drugs do not work for everyone but when they do they can truly make a difference to patients quality and quantity of life. Progress in this space has been phenomenal and we are confident that the next five years will deliver many more advances in the immunotherapy of lung cancer."

Louise Houson, UK Managing Director at MSD, added: "We are delighted with the news that pembrolizumab is being made routinely available for certain patients with untreated metastatic lung cancer. At MSD we are aware of the continuous need for new treatments for cancer. We want to play our part in addressing this situation, and today we are proud of the contributions that MSD’s innovative oncology medicines are making, giving hope for some patients."

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