FDA Grants Accelerated Approval to Jemperli for Locally Advanced Rectal Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Jemperli (dostarlimab-gxly) for adults with stage II or III rectal cancer whose tumors exhibit mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). This approval offers an immunotherapy-only treatment approach, potentially allowing eligible patients to avoid chemotherapy, radiation, and surgery. The approval was announced on October 19, 2026, and reported on October 25, 2026.