The FDA approved Merck & Co.’s Keytruda drug to treat tumors with a certain genetic defect—the first time the agency has cleared a cancer drug for a use not tied to the site of a tumor.
Merck & Co's immunotherapy Keytruda on Tuesday became the first cancer drug ever approved by the U.S. Food and Drug Administration based on a patients' specific genetic traits, regardless of where in the body the disease originated. The approval marks a major step in so-called precision medicine, where genetic biomarkers may determine the course of therapy rather than the type of cancer. "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.
Merck (MRK) presented data from a phase II study on its pipeline candidate MK-7264 (formerly AF-219) at the American Thoracic Society (ATS) Annual Conference.