The FDA approved an immunotherapy for some rectal cancer patients
Jemperli, or dostarlimab, received accelerated approval for untreated stage II or III dMMR or MSI-H rectal cancer. In a 154-patient trial, nearly three-fourths needed no chemo, radiation, or surgery after more than two years. That subtype is about 3 percent of rectal cancers.
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On Oct. 19, 2026, the Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for adults with previously untreated stage II or III rectal cancer that is mismatch-repair deficient (dMMR) or microsatellite instability-high (MSI-H). That subtype accounts for about 3 percent of rectal cancers. The approval does not apply to rectal cancer in general.
The evidence is the AZUR-1 trial. Of 154 patients treated with the immunotherapy, nearly three-fourths had not needed surgery, radiation, or chemotherapy after a median follow-up of more than two years. Accelerated approval still requires longer follow-up. The trial result is not a finding that every patient can skip those treatments, and it is not a statement that the cancer is cured.
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