FDA Grants Accelerated Approval for Immunotherapy Jemperli in Certain Rectal Cancers
The US Food and Drug Administration granted accelerated approval on October 19, 2026, for a new use of the immunotherapy drug Jemperli, also known as dostarlimab-gxly. The decision allows adults with previously untreated stage II or stage III locally advanced rectal cancer to receive the drug on its own, provided their tumors carry specific genetic markers known as dMMR or MSI-H. Rectal cancer patients facing this stage of illness usually undergo chemotherapy and radiation before surgery, treatments that can cause permanent bowel issues, sexual dysfunction, or colostomy bags. In an interim study of 154 patients, almost three-fourths of those treated with Jemperli avoided surgery, chemotherapy, and radiation after more than two years of median follow-up. This gives about 3% of patients with locally advanced rectal cancer a chance to avoid invasive standard therapies, though the manufacturer, GSK, must run further studies to confirm whether the benefits hold up over the long term.
What was announced
The FDA granted accelerated approval to GSK for Jemperli (dostarlimab-gxly) as a single agent in adults with untreated stage II or stage III locally advanced rectal cancer. To receive the drug, a patient must have a tumor determined by an FDA-authorized test to be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
Jemperli works by targeting PD-1, a protein on immune cells, which stops cancer cells from hiding from the body's immune defenses. The approval rested on interim results from the AZUR-1 phase 2 clinical trial involving 154 patients. Participants took up to nine doses across six months. After a median follow-up of more than two years, almost three-quarters of these patients did not require surgery, chemotherapy, or radiation. The agency also reviewed an earlier 50-patient study at Memorial Sloan Kettering Cancer Center, where all participants showed no detectable cancer after treatment. Common side effects include fatigue, rash, diarrhea, and itching, while severe immune reactions against healthy organs can also happen.
What it means
Standard treatment for locally advanced rectal cancer typically involves radiation and chemotherapy followed by surgery. Those standard options can cause life-altering harm, including sexual dysfunction, bowel and urinary problems, infertility, surgical leaks, or a permanent colostomy bag.
For the estimated 3% of patients whose tumors carry the dMMR or MSI-H traits, this approval provides a path to skip those procedures. The FDA cleared the application nearly four months ahead of schedule under Priority Review and Breakthrough Therapy designations. It was the 11th approval under the Commissioner’s National Priority Voucher pilot program.
What the announcement does not tell us
The FDA did not state how much Jemperli will cost patients or healthcare systems. The release also does not specify how long the drug's effects last beyond the median two-year mark tracked in the AZUR-1 trial. The agency noted that longer follow-up is needed to learn how often the cancer returns. Because this is an accelerated approval based on early findings, the FDA requires GSK to complete confirmatory studies, but the announcement does not outline the timeline or deadlines for those results.
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The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments that can have a lasting impact on their daily life.
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