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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.
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