GSK plc said on Sunday the U.S. Food and Drug Administration has accepted its supplemental biologics license application for Jemperli (dostarlimab) in previously untreated stage II and III mismatch repair deficient or microsatellite instability-high locally advanced rectal cancer.
The FDA’s Oncology Center of Excellence granted priority review status to the application and assigned a Prescription Drug User Fee Act action date of February 2027. The submission is also eligible for expedited review through the National Priority Voucher program and is being evaluated under Project Orbis, which facilitates concurrent international regulatory reviews.
Jemperli is not currently approved anywhere for locally advanced rectal cancer. The drug, originally discovered by AnaptysBio and licensed by TESARO before its acquisition by GSK, is administered as a 500mg intravenous infusion every three weeks for a total of nine cycles over six months. GSK previously received Fast Track and Breakthrough Therapy Designations for this indication.
The application is supported by data from the global, open-label AZUR-1 phase II study involving 154 patients. The trial met its primary endpoint by demonstrating a sustained clinical complete response rate for 12 months, with no detectable signs of cancer for at least one year. Interim safety and tolerability profiles were consistent with those observed in solid tumor indications. Full results are slated for presentation at a scientific congress later in 2026.
Rectal cancer affects approximately 770,000 people globally annually, with roughly 5% to 10% of cases classified as dMMR/MSI-H. Current standard treatment includes chemotherapy, radiation, and surgery.
