Keytruda Approved for All Cancers With Specific Genetic Biomarker
Of 149 individuals with such tumors who took Keytruda in clinical trials, nearly 40% had a complete or partial remission.
(HealthDay News) — 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% of patients with metastatic colorectal cancer have this biomarker.
Of 149 individuals with such tumors who took Keytruda in clinical trials, nearly 40% had a complete or partial remission. And for 78% of those patients, the drug's effects lasted 6 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.
- FDA approves first cancer treatment for any solid tumor with a specific genetic feature [press release]. U.S. Food & Drug Administration. May 23, 2017.