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FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery

  • The FDA granted accelerated approval on October 19, 2026, for Jemperli (dostarlimab-gxly) to treat adults with previously untreated stage II or stage III locally advanced rectal cancer.
  • The drug allows eligible patients to potentially avoid surgery, radiation, or chemotherapy, which often cause lasting impacts on bowel, urinary, sexual function, or fertility.
  • Eligibility requires tumors to be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), conditions found in approximately 3% of locally advanced rectal cancers.
  • Jemperli functions by blocking the PD-1 protein signal that cancer cells use to evade the immune system.
  • Approval was based on interim results from the AZUR-1 phase 2 study, where nearly three-fourths of 154 patients did not require surgery, radiotherapy, or chemotherapy after a median follow-up of over 2 years.
  • Supporting data from an earlier Memorial Sloan Kettering study showed 100% of 50 patients had no detectable cancer post-treatment, with 93% maintaining that status for at least 12 months.
  • The drug carries risks of severe or fatal immune-mediated reactions attacking healthy organs, with common side effects including fatigue, rash, diarrhea, and itching.
  • The application received Priority Review status and Breakthrough Therapy designation, marking the 11th approval under the Commissioner's National Priority Voucher pilot program.
  • GSK holds the approval for Jemperli, and the sponsor must continue long-term studies to confirm lasting clinical benefits as required by the accelerated approval pathway.