FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer

On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted Priority Review with a target action date of March 8, 2017; the sBLA will be reviewed under the FDA’s Accelerated Approval program based on tumor response rate and … (leggi tutto)