FDA Expands GSK’s Jemperli Approval for Endometrial Cancer
GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. Priority Review was granted to the supplemental Biologics Licence Application (sBLA) supporting this new indication, and it was authorized ahead of the Prescription Drug User Fee Act action deadline.
"Today's expanded approval of Jemperli redefines the treatment landscape for patients...
