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Merck's Keytruda approved in China as single therapy for lung cancer

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Merck & Co. Inc. said China's National Medical Products Administration approved blockbuster immunotherapy Keytruda for the initial treatment of patients with a common type of lung cancer.

Keytruda can now be used in China as a single therapy for patients with non-small cell lung cancer whose cancer has spread to nearby tissue or new areas of the body. These patients' tumors must express programmed death-ligand 1 — a protein found in cancer not yet treated with chemotherapy — and have no mutations in the epidermal growth factor receptor or anaplastic lymphoma kinase genes.

Epidermal growth factor receptor and anaplastic lymphoma kinase genes are involved in cell growth and their mutation can make tumor cells grow faster.

The approval was based on the results of a late-stage study, called Keynote-042, which showed Keytruda, or pembrolizumab, helped previously untreated lung cancer patients live longer, the Kenilworth, N.J.-based drugmaker said.

Keytruda is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease. The drug is already approved in the U.S. in multiple cancer indications.

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