Wednesday, May 24, 2017

FDA Clears First Cancer Drug Based on Genetics of Disease, Not Tumor Location - Scientific American

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. "We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location."
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