
The FDA approved Jemperli for some adults with previously untreated stage II or III locally advanced rectal cancer.
Eligibility also requires dMMR or MSI-H tumor characteristics, confirmed with an FDA-authorized test.
These markers reflect problems repairing DNA-copying errors, which can produce proteins the immune system recognizes.
Jemperli blocks PD-1, a protein on immune cells, helping them act against cancer cells that use shielding signals.
In AZUR-1, almost three-fourths of 154 participants had not needed surgery, radiation, or chemotherapy after median follow-up exceeding two years.
Interim findings cannot show how long responses last or how often cancer returns; continued patient monitoring is required.
Jemperli may cause severe or fatal immune attacks on healthy tissues; fatigue, rash, diarrhea, and itching were common.
Explore the FDA announcement for eligibility details, trial findings, safety information, and the approval’s remaining uncertainties.