Health

FDA clears dostarlimab for rectal cancer that may spare patients chemo, radiation and surgery

Washington, D.C. • October 25, 2026 • By Press Pass USA

Editorial illustration: a scientist in a cancer research laboratory holding a vial

Illustration: Press Pass USA

The Food and Drug Administration has granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer whose tumors carry the MSI-H or dMMR biomarkers — an immunotherapy-only path that, for many patients in the trial, meant no detectable cancer a year or more later without chemotherapy, radiation or surgery.

The approval, issued October 19, covers patients whose tumors are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test. About 5 to 10 out of every 100 rectal cancers carry those biomarkers, according to the Colorectal Cancer Alliance. GSK, which markets the drug, describes it as the first and only immunotherapy approved for this population.

The evidence comes from AZUR-1, a single-arm trial of 154 previously untreated patients who received dostarlimab intravenously every three weeks for nine cycles. Patients whose cancer showed a clinical complete response entered close monitoring instead of immediate surgery, with checkups every four months for the first two years.

By investigator assessment, 68% of evaluable patients (98 of 144) achieved a clinical complete response sustained for 12 months, and 76% had no evidence of cancer one year or more after treatment, GSK reported. No disease recurrences had been reported among responders after a median follow-up of more than two years. Full data from the trial were presented as a late-breaking abstract at the ESMO Congress in Madrid on October 25.

Accelerated approval means the drug reached patients on early evidence of benefit; confirmatory evidence is still part of the approval pathway. Patients who did not reach a complete response, or whose disease returned, were evaluated for standard treatment.

Sources: U.S. Food and Drug Administration (Oct 19, 2026); GSK via GlobeNewswire (Oct 19, 2026); Colorectal Cancer Alliance (Oct 2026); Oncology Nursing Society (Oct 2026).