Posted by Michael Wonder on 10 Aug 2021
FDA accepts application for Merck’s Keytruda (pembrolizumab) as single agent for certain patients with MSI-H/dMMR advanced endometrial carcinoma
10 August 2021 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application seeking approval for Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 28 March 2022.
