FDA Grants Priority Review to GSK's Jemperli 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) for patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. The submission is supported by positive data from the registrational phase II, single-arm AZUR-1 trial, which demonstrated a meaningful and sustained clinical complete response rate for 12 months. If approved, Jemperli could potentially eliminate or delay the need for chemotherapy, radiation, and surgery for some patients in this population. The FDA has assigned a PDUFA action date of February 2027.