FDA Approves First Immunotherapy for a Common Form of Rectal Cancer
The US FDA granted accelerated approval on 19 October 2026 to dostarlimab (Jemperli) for adults with stage II/III locally advanced rectal cancer carrying a specific genetic marker, with 71% of trial patients needing no further treatment beyond the drug alone.
On 19 October 2026, the US Food and Drug Administration granted accelerated approval to dostarlimab (Jemperli) for adults with stage II or III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR), as confirmed by an FDA-authorised test for solid tumours. The approval was based on results from the multicenter, single-arm, open-label AZUR-1 trial enrolling 154 patients with previously untreated MSI-H/dMMR locally advanced rectal cancer. Notably, 71% of patients in the trial needed no additional treatment — no chemotherapy, radiation, or surgery — beyond the dostarlimab regimen alone. The drug is given at 500 mg intravenously every three weeks for up to nine cycles. The FDA reviewed the application four months ahead of its goal date, conducting the review under Project Orbis alongside Health Canada, Israel's Ministry of Health, Switzerland's Swissmedic, and the UK's Medicines and Healthcare products Regulatory Agency. The application also received Priority Review and Breakthrough Therapy designations. These results raise the prospect that some rectal cancer patients may be able to avoid the significant side-effects of standard chemoradiation and surgery, representing a potential quality-of-life advance for this group.
