FDA approves drug that may let some rectal cancer patients skip surgery
The FDA has approved GSK's Jemperli for a type of rectal cancer tied to certain gene changes, Time, MedCity News and Healio reported. In a key study, 68% of patients had no sign of cancer after a year. Some may avoid surgery, chemo and radiation.
The Food and Drug Administration has approved the drug Jemperli for some people with rectal cancer, according to Time, MedCity News and Healio. The drug could let some patients skip chemotherapy, radiation and surgery.
The FDA approved the drug, made by GSK, on October 19, Time and Healio reported. Its generic name is dostarlimab.
The approval covers adults with stage II or III rectal cancer that is locally advanced, MedCity News reported. The tumor must have a genetic trait that keeps cells from fixing damage to their DNA. Time said this kind accounts for 5% to 10% of rectal cancers. Patients need an FDA-approved test to show their tumor has the trait, MedCity News said.
Jemperli helps the immune system find and attack cancer cells, Time reported. Patients in the study got nine doses by IV, once every three weeks, Time and Healio reported.
The FDA based its decision on a GSK study of 154 patients, the outlets reported. A year later, 68% of patients had no sign of cancer that doctors could find, Time and Healio said. After about two years, nearly three-fourths had not needed surgery, radiation or chemotherapy, MedCity News reported.
Standard treatment can include surgery to remove the rectum, Time reported. Many patients then need a colostomy bag for life. Treatment can also harm fertility and sexual function, Healio said.
"We have completely leapfrogged over standard of care with a simple immunotherapy that melts the tumor away," said Luis Diaz of Memorial Sloan Kettering Cancer Center, according to Time.
Serious side effects affected 20% of patients, Healio reported. The most common were fatigue, rash and diarrhea.
This is an accelerated approval based on early results, MedCity News reported. GSK must submit more data to show the benefit lasts. Jemperli was first approved in 2021 for endometrial cancer. It is now GSK's top-selling cancer drug, the outlet said.
What we know: The FDA approved Jemperli on October 19 for one type of rectal cancer.
What we don't: How long the benefit lasts, which GSK must still show.
Where outlets agree Time, MedCity News and Healio report that the FDA approved Jemperli for locally advanced rectal cancer with a specific genetic trait, based on a study of 154 patients.
Where they differ The cited reports agree on the key facts so far.