Shots:

• The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg- q3w) in 90 patients with MSI-H/dMMR advanced EC with disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation
• This indication is approved under accelerated approval- based on tumor response rate & DoR while the continuous approval is contingent on verification & description of clinical benefit in confirmatory studies
• Keytruda + Lenvima received accelerated & full approval in Sept’19 & Jul’21 in for advanced EC respectively. The anticipated PDUFA date is Mar 28- 2022

Ref: Merck | Image: Merck