GSK's Jemperli Receives Priority Review from FDA for Locally Advanced Rectal Cancer
The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab), a drug developed by GSK. This application targets patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. The FDA has set a PDUFA action date for February 2027. The application is also eligible for expedited review through the National Priority Voucher program, potentially leading to an earlier FDA decision. This submission is supported by positive data from the registrational phase II, single-arm AZUR-1 trial, which demonstrated a significant and sustained clinical complete response rate for 12 months, meaning no detectable signs of cancer for at least one year. The safety profile of dostarlimab in this trial was consistent with its known and manageable safety profile observed in other solid tumors. Jemperli was previously granted Fast Track and Breakt... 
