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Merck's Keytruda gets NICE backing as first-line lung cancer therapy in NHS

The U.K.'s National Institute for Health and Care Excellence recommended Merck & Co. Inc.'s Keytruda for routine use by the country's National Health Service as a first-line lung cancer treatment.

The drug will now be available as an option for previously untreated patients with non-small-cell lung cancer, or NSCLC, which has spread to other parts of the body, expresses a level of the PD-L1 protein that meets or exceeds 50%, and is without the EGFR or ALK genomic tumor aberrations that drive cancer cell growth, NICE said in a statement.

Keytruda belongs to a group of tumor-targeting drugs that block either the programmed cell death-1, or PD-1 protein, on healthy cells or the PD-L1 protein on cancer cells, boosting the body's immune response to the cancer.

The drug is currently available for routine NHS use only for patients with PD-L1-positive advanced or metastatic NSCLC, who had at least one round of chemotherapy.

For the first-line lung cancer treatment, the drug was selectively available through the Cancer Drugs Fund, which enables patients to receive medicines not recommended by NICE because they have not been deemed cost-effective.

NICE, the government's health-cost adviser, had earlier rejected the drug for first-line lung cancer treatment citing its high cost and lack of data on whether it helps patients live longer.

The latest recommendation comes on the basis of data from the Keynote-024 study, which demonstrated that Keytruda extended patients' lives by 16 months more than standard chemotherapy.

Merck also offered a confidential discounted price to the NHS for Keytruda, which costs an average of £84,000 for a course of treatment. In 2016, the average cost of a course of treatment with Keytruda was £29,114 at its full list price.

The drug's use is based on the conditions that it is offered at the discounted price and is stopped at two years of uninterrupted treatment, or earlier, in case the disease continues to grow.

NICE expects to publish final guidance in June, if no organizations appeal the decision, after which the drug will be available on the NHS within 30 days.

About 1,800 patients a year will be eligible for the medicine, NICE said.