The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer whose tumors are MSI-H or mismatch repair-deficient. The decision is based on AZUR-1, a multicenter, single-arm, open-label trial evaluating dostarlimab in previously untreated patients. In AZUR-1, investigators reported a 12-month clinical complete response rate of 47% among evaluable patients by independent central review, alongside a 79% objective response rate. After a median follow-up of 26.3 months, the report said patients achieving clinical complete response did not experience disease progression. Clinically, the approval expands checkpoint therapy use into a biomarker-defined, nonoperative management pathway for a subset of rectal cancer patients. It also reinforces FDA’s continued reliance on response durability metrics and central review criteria for accelerated approvals in oncology.