Posted by Michael Wonder on 28 Nov 2016
FDA grants priority review to Merck’s supplemental biologics license application seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer
28 November 2016 - Merck today announced that the U.S. FDA accepted for review the supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer.
The FDA granted priority review with a PDUFA, or target action date, of March 8, 2017; the application will be reviewed under the FDA’s accelerated approval program based on tumour response rate and durability of response.
The FDA recently granted breakthrough therapy Designation to Keytruda for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer.
