Keytruda Wins Expanded Melanoma Priority Review; Also A Delay
This article was originally published in Scrip
Executive Summary
The FDA has granted a priority review for Merck's supplemental biologics license application (sBLA) for its human programmed death receptor-1 (PD-1)-blocking antibody Keytruda (pembrolizumab) at the 2mg/kg every three weeks dosage as a first-line treatment for patients with unresectable or metastatic melanoma.