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Rectal Cancer Patients May Skip Chemo, Radiation, Surgery
20 Oct
Summary
- FDA approved Jemperli for certain adults with untreated rectal cancer.
- Treatment avoids surgery, radiation, and chemotherapy for some patients.
- Nearly 3 in 4 patients in a trial went without standard treatments.
On Monday, October 19, 2026, the U.S. Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly), an immunotherapy, for certain adults with untreated rectal cancer. This approval offers a significant alternative to traditional treatment plans that typically involve chemotherapy, radiation, and surgery.
These standard treatments can lead to lasting issues with bowel, bladder, and sexual function, and may impact fertility. Some patients may require a permanent colostomy. The FDA's Oncology Center of Excellence noted that for specific rectal cancers, Jemperli provides a groundbreaking option that avoids these life-changing side effects.
The approval applies to adults with stage 2 or 3 rectal cancer that has a specific DNA repair deficiency. This flaw makes the cancer more detectable by the immune system. Early trial data indicated that nearly three-quarters of patients receiving Jemperli for six months avoided surgery, radiation, or chemotherapy.
An earlier study at Memorial Sloan Kettering Cancer Center showed no signs of cancer in any patients after treatment. Of those tracked for at least three years, only one experienced cancer recurrence. GSK, the manufacturer, described the approval as a step toward more personalized care.
One patient advocate, Jessica Acosta, shared her experience of being cancer-free after receiving Jemperli during its trial phase for a rectal tumor. The FDA cleared Jemperli under its accelerated approval program, and GSK will continue to monitor patients to confirm the durability of the treatment's benefits.
