Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

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

Click here to read full press release/ article | Ref: Merck | Image: Fortune