The U.S. Food and Drug Administration granted accelerated approval on October 19, 2026, for a new use of the immunotherapy Jemperli (dostarlimab-gxly). The approval allows some patients with locally advanced rectal cancer to avoid chemotherapy, radiation, and surgery.

The approval applies to adults with previously untreated stage II or stage III locally advanced rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). Approximately 3% of locally advanced rectal cancers are dMMR or MSI-H.

Jemperli is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody. In an earlier study of 50 patients, 93% maintained cancer-free status for at least 12 months. Common side effects reported in at least 15% of patients include fatigue, rash, diarrhea, and itching. A study titled "Dostarlimab (Jemperli)" was published in 2022 in Canadian Journal of Health Technologies. Primary sources: doi.org, fda.gov

Standard treatments for locally advanced rectal cancer often include chemotherapy and radiation prior to surgery. These interventions can affect bowel, urinary, and sexual function, as well as fertility. Surgery carries risks of serious complications, including poor healing and leaks where the bowel is reconnected, and can result in permanent colostomy for some patients.

Why It Matters

The accelerated approval provides an alternative to standard care protocols that involve functional risks and potential permanent surgical alterations. Acting FDA Commissioner Kyle Diamantas said, "The FDA is committed to closing the gap between scientific progress and patient access, and that commitment has to show up not just in policy, but in the pace of our work." He added, "American patients deserve timely access to innovative treatments, and the Trump Administration is making that a reality."