FDA Grants Accelerated Approval to Jemperli for Stage II/III dMMR/MSI-H 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 characterized by mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). This approval, initially announced on October 19, 2026, offers an immunotherapy-only approach that may allow some patients to avoid chemotherapy, radiation, and surgery. Further results from the AZUR-1 trial supporting this approval were presented at the ESMO Congress on October 25, 2026.