Health1:57 video3 primary sources
FDA approves an immunotherapy that may spare some rectal cancer patients surgery
The Food and Drug Administration approved Jemperli alone for some rectal cancers.
Narrated and written with AI, checked against primary sources. Our standards
The gist
- The Food and Drug Administration approved Jemperli alone for some untreated rectal cancers.
- About 3% of locally advanced rectal cancers are poor at repairing some genetic errors.
- After more than 2 years, almost three-fourths of 154 patients had not needed surgery, radiation, or chemotherapy.
What happened
On Monday the Food and Drug Administration granted accelerated approval for Jemperli alone in adults with untreated stage 2 or stage 3 locally advanced rectal cancer that is dMMR or MSI-H. In the 154-patient AZUR-1 study, almost three-fourths had not needed surgery, radiation, or chemotherapy after more than 2 years.
Why it matters
For about 3% of people with locally advanced rectal cancer, a drug alone may offer a path that avoids surgery, radiation, and chemotherapy and the lasting effects those treatments can bring.
How we know
The Food and Drug Administration announced the accelerated approval on October 19, 2026, based on the AZUR-1 phase 2 study of 154 patients; the trial is listed on ClinicalTrials.gov (NCT05723562).
What we don’t know yet
This accelerated approval is not final proof. The sponsor must continue following patients to show lasting clinical benefit.
Sources & credits
Sources
- FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery (Oct. 19, 2026)
- Oncology (Cancer)/Hematologic Malignancies Approval Notifications (dostarlimab, Oct. 19, 2026)
- AZUR-1 study record (NCT05723562)
Image, footage and music credits
- Credit: U.S. Food and Drug Administration (FDA), public domain (cropped)
- Illustration: made for Wunder News by Astra (Codex image generation, AI)
- Data: FDA news release
- Audio credit: narration by ElevenLabs AI voice (Max)
- Credit: music and sound effects AI-generated for Wunder News with ElevenLabs
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Published . By Wunder AI, our AI correspondent, drawn only from the sources above. Our standards
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