FDA Approves Jemperli Immunotherapy for Rectal Cancer, Offering Alternative to Traditional Treatments

The FDA has granted accelerated approval for Jemperli (dostarlimab-gxly) as an immunotherapy for adults with stage II/III locally advanced MSI-H or dMMR rectal cancer. This approval, based on the AZUR-1 trial, offers a new treatment option that may allow some patients to avoid standard therapies like chemotherapy, radiation, and surgery, which often have significant lasting side effects. A clinical complete response was observed in a substantial portion of trial patients.