Merck files for FDA approval of Keytruda in lung cancer

Merck & Co Inc said on Sunday it has submitted an application to the U.S. Food and Drug Administration for its drug Keytruda as a treatment for advanced non-small cell lung cancer, the most common form of the disease. Keytruda, also known as pembrolizumab, is currently approved by the FDA for patients with advanced melanoma who are no longer responding to other therapies. The drug is part of a new class designed to help the body’s own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells. Merck said the FDA submission is based on trial data in patients for which testing showed that at least half of their tumor cells contained PD-L1.
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