FDA Approves Immunotherapy That May Let Some Rectal Cancer Patients Skip Chemo, Radiation and Surgery
Jemperli is cleared for adults with a rare tumor subtype, and in a trial almost three-quarters of patients did not need those treatments.
Photo: The U.S. Food and Drug Administration / Public domain via Wikimedia Commons
The U.S. Food and Drug Administration on 19 October 2026 granted accelerated approval to GSK's immunotherapy Jemperli (dostarlimab-gxly) as a first treatment for some adults with locally advanced rectal cancer, offering certain patients a path that may avoid chemotherapy, radiation and surgery.
Who it is for
The approval covers adults with previously untreated stage II or III rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), as identified by an FDA-authorized test. The agency estimates that this describes about 3% of locally advanced rectal cancers. Jemperli blocks PD-1, a protein that tumors use to hide from the immune system.
What the evidence shows
- 154 patients took part in the interim phase 2 AZUR-1 trial, receiving up to nine doses every three weeks over about six months.
- After more than two years of median follow-up, almost three-fourths had not needed surgery, radiotherapy or chemotherapy.
- In a separate earlier study at Memorial Sloan Kettering with 50 patients, none had detectable cancer after treatment and 93% stayed cancer-free for at least 12 months.
"A groundbreaking option that avoids surgery, radiation and chemotherapy." — Angelo de Claro, director of the FDA's Oncology Center of Excellence
Why it matters
Standard rectal cancer care can involve life-altering surgery and lengthy radiation and chemotherapy. For people in this small subgroup, a few months of immunotherapy may replace all three. The FDA completed its review nearly four months ahead of schedule.
Context and caveats
This is an accelerated approval based on interim results, so the sponsor must keep following patients to confirm lasting benefit. Longer follow-up will show how long responses last and how often cancer returns. Jemperli can also cause immune reactions against healthy organs, which can be serious; the most common side effects were fatigue, rash, diarrhea and itching. Patients should discuss options with their care team.
