FDA Grants Accelerated Approval for Immunotherapy in Locally Advanced Rectal Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Jemperli (dostarlimab-gxly) for adults with stage II/III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This approval may allow some patients to avoid traditional treatments like chemotherapy, radiation, and surgery, which can have significant lasting impacts on quality of life. The approval is based on the AZUR-1 trial, where a significant percentage of patients achieved a clinical complete response with dostarlimab alone.