The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer that is MSI-H or dMMR. The approval is based primarily on findings from the multicenter, single-arm AZUR-1 trial. In AZUR-1, evaluable patients achieved a 47% 12-month clinical complete response rate and a 79% objective response rate assessed by independent central review. After a median follow-up of 26.3 months, the company reported no disease progression among patients who achieved cCR12 or other complete response measures. The dosing strategy—500 mg every three weeks for nine cycles—enabled a “nonoperative management” path for patients reaching cCR on early post-treatment assessments, while others moved to surgery and additional therapy as clinically indicated. The accelerated approval adds to the growing biomarker-defined immunotherapy options in rectal cancer, where treatment pathways increasingly hinge on MSI-H/dMMR status and response durability.