FDA Approves Jemperli for Certain Patients with 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 that exhibits mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). This immunotherapy-only approach may allow some patients to avoid chemotherapy, radiation, and surgery. The approval, initially announced on October 19, 2026, was supported by the AZUR-1 clinical trial, which showed a clinical complete response lasting at least 12 months in 47% of evaluable patients.