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FDA Approves Keytruda for All Cancers With Genetic Biomarker

WEDNESDAY, May 24, 2017 -- Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker, regardless of where in the body the cancer originated.

The cancers targeted by this new drug have a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), the agency explained Tuesday in a news release. MSI-H/dMMR tumors are most often found in colorectal, endometrial, or gastrointestinal cancers, the FDA said. About 5 percent of patients with metastatic colorectal cancer have this biomarker.

Of 149 individuals with such tumors who took Keytruda in clinical trials, nearly 40 percent had a complete or partial remission. And for 78 percent of those patients, the drug's effects lasted six months or more, the FDA said. The drug's most common side effects included fatigue, pruritus, diarrhea, loss of appetite, rash, pyrexia, cough, and dyspnea.

Merck & Co.'s Keytruda, first FDA-sanctioned in 2014, previously was approved to treat metastatic melanoma, metastatic non-small-cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin's lymphoma, and urothelial carcinoma.

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Posted: May 2017