1 August 2024,London,UK:US FDA expands Jemperli (dostarlimab) plus chemotherapy approval - oncology

The US Food and Drug Administration (FDA) has expanded its approval of Jemperli to all adult patients with primary advanced or recurrent endometrial (uterine) cancer as the first and only immuno-oncology based treatment to show an overall survival benefit.Jemperli approval now includes MMRp/MMS tumours,which represent a majority of endometrial cancer cases.Jemporli plus chemotherapy demonstrated a significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone.GlaxoSmithKline announced today that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paditaxel (chemotherapy) followed by Jemperli as a single agent for adult patients with primary or recurrent endometrial cancer.Said Hesham Abdullah,Senior Vice President,Global Head Oncology,R and D,GlaxoSmithKline:We are thrilled this option is now available for more patients in the US,including the 70-75% with MMrp/MMS tumours whose treatment options have been limited.*Press release by GlaxoSmithKline and edited by Andrew Taylor*GlaxoSmithKline plc (LSE/NYSE:GSK)