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FDA Clears Cancer Drug Keyed to Genetics

Merck & Co’s immunotherapy Keytruda chalked up another approval on Tuesday as the U.S. Food and Drug Administration said the cancer medicine can be used to treat children and adults who carry a specific genetic feature regardless of where the disease originated.

It is the first time the agency has approved a cancer treatment based solely on a genetic biomarker.

“Until now, the FDA has approved cancer treatments based on where in the body the cancer started – for example, lung or breast cancers,” said Richard Pazdur, head of oncology products for the FDA’s Center for Drug Evaluation and Research.

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