GSK plc said the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application for Jemperli (dostarlimab) to treat previously untreated stage II and III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
The drug, discovered by AnaptysBio and licensed by TESARO before its acquisition by GSK, is currently not approved globally for this indication. The FDA’s Oncology Center of Excellence designated the application for expedited review under Project Orbis, which facilitates concurrent submissions in multiple countries. The regulator also assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2027.
The application is supported by data from the global, open-label, single-arm AZUR-1 phase II trial, which enrolled 154 patients. The study met its primary endpoint, demonstrating a sustained clinical complete response rate for 12 months with no detectable cancer signs for at least one year. Interim results indicated a safety profile consistent with observations in solid tumors.
Rectal cancer affects roughly 770,000 people annually worldwide, with an estimated 5% to 10% of cases classified as dMMR/MSI-H. Current standard treatments include chemotherapy, radiation, and surgery. GSK plans to present full trial data at a scientific congress in 2026.
