Keytruda gets first-ever biomarker-specific approval

FDA granted accelerated approval to Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) to treat advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. The drug is the first cancer treatment to gain FDA approval based on a specific biomarker, regardless of the cancer's tissue of origin (see BioCentury, June 8, 2015 & BioCentury, June 13, 2016).

The application was based on data from five open-label Phase I/II trials, in which Keytruda led to a complete or partial response in 39.6% of patients. The trials enrolled a total of 149 patients across 15 cancer types...