FDA grants accelerated approval to dostarlimab for a defined rectal-cancer group
The approval covers adults with Stage II or III locally advanced rectal cancer with MSI-H or dMMR tumors identified by an FDA-authorized test.
What the record says
The FDA announced October 19 that it granted accelerated approval to dostarlimab, marketed as Jemperli, for adults with Stage II or III locally advanced rectal cancer whose tumors are microsatellite instability-high or mismatch repair deficient, as determined by an FDA-authorized test. The agency reviewed single-arm, open-label studies, including the 154-patient AZUR-1 trial. Some participants were managed without surgery or additional cancer treatment, while others required further treatment. FDA's notice also lists warnings for immune-mediated adverse reactions, infusion-related reactions, transplant complications and embryo-fetal toxicity.
Source details and supporting locations.
Practical next step
Patients with questions about whether this approval applies to them should discuss the exact tumor-testing requirements, benefits, risks and monitoring needs with their oncology team.
Limits and what is not established
This is an accelerated approval for a defined patient group, not a cure claim or approval for every rectal cancer. Single-arm trial findings do not establish that every eligible patient can safely avoid surgery, chemotherapy or radiation. Treatment and ongoing monitoring require specialist care.
Sources checked October 20, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information