FDA Accepts Jemperli for Priority Review in Stage II and III dMMR/MSI‑H Locally Advanced Rectal Cancer

The U.S. FDA has granted priority review to a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in previously untreated stage II and III dMMR/MSI‑H locally advanced rectal cancer. This submission is supported by positive data from the Phase 2 AZUR‑1 trial, which demonstrated a meaningful and sustained clinical complete response rate for 12 months. The FDA has set a PDUFA action date for February 2027.