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MAY 26, 2017

FDA Approves First Therapy for Specific Biomarker Rather Than Tumor Site

By PPN News Staff

The FDA has granted a new indication for pembrolizumab (Keytruda, Merck) to treat adult and pediatric patients who have a specific genetic feature. This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Pembrolizumab will be indicated for unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have