The European Commission has granted conditional marketing authorisation to GlaxoSmithKline (GSK) for Jemperli (dostarlimab), making it the first anti-PD-1 therapy available for endometrial cancer in Europe.
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.
“Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis,” said Dr Hal Barron, Chief Scientific Officer and President R&D, GSK.
“Today’s approval of dostarlimab means that for the first time in Europe, these women will have access to a new, innovative and much-needed therapy.”
The European Medicine Agency’s approval is based on results from the multi-cohort GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen in cohort A1.