FDA grants accelerated approval for immunotherapy alone in selected rectal cancer
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On October 19, 2026, FDA announced a new indication for dostarlimab-gxly. Eligibility requires previously untreated adult stage II/III locally advanced rectal cancer and dMMR or MSI-H established by an FDA-authorized test.
FDA cites interim AZUR-1 phase 2 results in 154 patients. After median follow-up exceeding two years, approximately three quarters had not required surgery, radiation or chemotherapy. This is not a cure rate or overall-survival estimate.
Summary
Jemperli monotherapy receives accelerated approval for untreated adults with stage II/III locally advanced dMMR/MSI-H rectal cancer.
Editorial view
Editorial view: organ preservation is an important outcome alongside tumor response.
Evidence and limitations
Accelerated approval requires further follow-up to confirm lasting benefit. Immune-mediated reactions can be severe or fatal. Do not extrapolate to all rectal cancers, prevention, longevity in healthy people or Korean authorization.