FDA approves immunotherapy to spare some rectal cancer patients major treatments
The U.S. Food and Drug Administration granted accelerated approval for Jemperli to help certain rectal cancer patients avoid chemotherapy, radiation, and surgery.
Adults with stage II or III locally advanced rectal cancer now have a new treatment option available. Eligible patients must have tumors showing specific genetic markers determined by an authorized test for approval consideration.
Standard treatment often involves chemotherapy and radiation before surgery which can permanently affect bowel function and sexual health for many individuals. Surgery also carries serious risks of poor healing or permanent colostomy that significantly alter daily life.
Interim results from a phase 2 study involving 154 patients showed that nearly three-fourths did not need surgery, radiotherapy, or chemotherapy after treatment. An earlier study of 50 patients found that almost all maintained a cancer-free state for at least twelve months duration.
The FDA based this decision on interim data while mandating additional research to ensure these therapies deliver enduring advantages to those treated. The approval marks the 11th drug reviewed under a pilot program designed to accelerate therapies addressing national public health priorities.
“American patients deserve timely access to innovative treatments, and the Trump Administration is making that a reality.”