GSK (NYSE:GSK) announced today that the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli (dostarlimab) combined with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer.
The decision marks the beginning of a formal review process by the EMA's Committee for Medicinal Products for Human Use, with a recommendation to the European Commission expected in the first half of 2025.
Currently, Jemperli is approved for patients whose cancer exhibits certain biomarkers, but the new submission aims to broaden its accessibility.
This move is supported by results from the RUBY phase III trial, which demonstrated a statistically significant and clinically meaningful progression-free and overall survival benefit.