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News From the Food and Drug Administration
July 4, 2017

Precision Approach in Cancer Care

JAMA. 2017;318(1):20. doi:10.1001/jama.2017.7641

For the first time the FDA has approved a cancer treatment based on tumor biomarkers rather than the site in the body where a tumor originated. The agency’s action brings cancer therapy a step closer to precision medicine approaches that consider individual patient characteristics in treatment choices.

Pembrolizumab’s new indication is for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors or colorectal cancer that has progressed despite treatment with fluoropyrimidine, oxaliplatin, or irinotecan.