Can Jemperli Replace Surgery for Rectal Cancer? Who FDA’s 2026 Approval Covers

Short answer: On October 19, 2026, the US Food and Drug Administration gave Jemperli (dostarlimab) an accelerated approval for a narrowly defined group of adults with locally advanced rectal cancer. Some trial participants avoided surgery, radiation and other systemic treatment during the reported follow-up. The approval does not mean those treatments are unnecessary for every person with rectal cancer, or that a lasting cure has been established.

Who is covered by the new US approval?

The FDA announcement describes adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch-repair deficient (dMMR) or microsatellite-instability high (MSI-H). An FDA-authorized test must establish that tumor characteristic. These stages have not spread to distant organs. FDA cites published estimates suggesting that only about 3% of locally advanced rectal cancers have dMMR or MSI-H. This is not a broad approval for all rectal cancers.

Did the trial show that surgery can always be skipped?

No. In the FDA’s account, the main evidence came from AZUR-1, an open-label, single-arm phase 2 trial of 154 people. At the data cutoff, 110 participants (71%) had received dostarlimab without another form of treatment and had not experienced disease progression. But 26 (17%) had surgery, with or without other treatment, and 13 (8%) received additional systemic treatment or radiation. Four withdrew or were lost to follow-up. The 71% figure is not a permanent cure rate and cannot predict what will happen to any one patient.

The FDA also reviewed a separate, investigator-led study of 50 people. These studies did not randomly compare dostarlimab with standard care. Median follow-up in AZUR-1 was 26.3 months, so longer observation is needed to understand recurrence and durable benefit. In the non-operative approach studied, patients were not simply discharged: they underwent repeated endoscopy and imaging to watch for recurrence.

What does “accelerated approval” change?

It permits this specified US use based on promising interim outcomes while requiring continued evidence of lasting clinical benefit. It is not itself a Korean authorization or reimbursement decision. Nor is it a recommendation to abandon surgery or chemoradiation outside the population and monitoring conditions described by FDA.

What risks matter?

Checkpoint immunotherapy can trigger the immune system to attack healthy organs and tissues; reactions can be serious or fatal. FDA lists fatigue, rash, diarrhea and itching among the common adverse effects in this rectal-cancer population. Eligibility, the benefits and risks of a non-operative approach, and follow-up planning depend on individual test results and specialist assessment. This article does not direct personal treatment.

Scope and review: FDA announcement and approval summary dated October 19, 2026. Jurisdiction: United States. Population: specified adults with dMMR/MSI-H stage II/III locally advanced rectal cancer. Prepared by Life Choice Note as an independent personal-health explainer; reviewed October 20, 2026.

Primary sources: FDA announcement (October 19, 2026); FDA approval and trial summary (October 19, 2026).