New Drug Could Let Some Rectal Cancer Patients Skip Chemotherapy, Radiation And Surgery

Some people with rectal cancer may now be able to skip chemotherapy, radiation and surgery.

The U.S. Food and Drug Administration (FDA) on Monday approved the immunotherapy Jemperli (dostarlimab-gxly) for certain adults with rectal cancer that hasn’t been treated yet.

The standard plan for this cancer often starts with chemotherapy and radiation, followed by surgery. Those treatments can leave lasting problems with bowel, bladder and sexual function. They can also affect fertility. 

Some patients end up with a permanent colostomy, an opening in the belly that empties waste into a bag.

“Standard treatment for rectal cancer has major life-changing effects,” said Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence. “For certain types of rectal cancer, this approval represents a groundbreaking option that avoids surgery, radiation and chemotherapy.”

The approval covers adults with stage 2 or stage 3 rectal cancer. At these stages, the cancer has moved into nearby tissue or lymph nodes but hasn’t reached other organs.

A lab test must also confirm a certain kind of tumor. Normally, cells catch and fix small mistakes when they copy their DNA. In these tumors, that repair system is broken, so mistakes pile up. That makes the cancer easier for the immune system to spot.

Only a small share of rectal cancers have this trait, according to the FDA.

The FDA based its decision on early results from a trial of 154 patients. They got the drug through an IV every three weeks for six months, up to nine doses total.

After more than two years of follow-up, nearly 3 in 4 patients had gone without surgery, radiation or chemotherapy, the FDA said.

An earlier study at Memorial Sloan Kettering Cancer Center tested the drug in 50 patients. None showed signs of cancer after treatment. Among 27 people tracked for at least three years, the cancer came back in just one, according to the FDA.

Tony Wood, chief scientific officer at GSK, which makes Jemperli, called the approval “an important step towards more personalized care for these patients.”

Jessica Acosta, a patient advocate and GSK spokesperson, recently spoke with HealthDay News. She was 29 when doctors found a 6-centimeter rectal tumor in early 2024. 

Because her tumor had the DNA repair flaw, she received Jemperli while it was still in trials instead of chemotherapy, radiation and surgery. By September 2024, she had no evidence of disease.

“You’re the only person that lives in your body on a daily basis,” Acosta told HealthDay News. “And so you’re the best person to advocate for it.”

The FDA cleared Jemperli under its accelerated approval program, which lets promising treatments reach patients sooner based on early data. 

GSK must keep tracking patients to show the benefits last. It’s still unknown how often the cancer may return over the long term.

More information

Visit the National Cancer Institute for more information about rectal cancer.

SOURCES: U.S. Food and Drug Administration, Oct. 19, 2026; GSK, news release, Oct. 19, 2026; HealthDay News interview, Oct. 19, 2026