GSK: FDA accepts expanded Jemperli indication application for priority review

GSK announced the U.S. Food and Drug Administration accepted the supplemental Biologics License Application, or sBLA, for Jemperli in combination with standard-of-care chemotherapy to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer. This would include patients with mismatch repair proficient /microsatellite stable tumours. Currently, Jemperli is FDA-approved in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high. The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of August 23, 2024.