Jemperli rectal cancer approval may let some patients skip standard treatment
October 20, 2026
The Jemperli rectal cancer approval, granted by the FDA on October 19, 2026, is an accelerated approval of Jemperli (dostarlimab-gxly) for previously untreated stage II or stage III locally advanced rectal cancer. The agency noted that some patients may skip chemotherapy and radiation, which can impair bowel, urinary and sexual function as well as fertility. Review finished nearly four months ahead of the original target.
Jemperli is approved as monotherapy for adults whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), confirmed by an FDA-authorized test. Published estimates place these features in approximately 3% of locally advanced rectal cancers, so the eligible population is small.
Jemperli rectal cancer approval: trial evidence and safety
Interim results from the AZUR-1 trial (NCT05723562) backed the decision. The phase 2 study gave up to nine doses of Jemperli, given every 3 weeks over 6 months, to 154 patients. After a median follow-up of more than 2 years, almost three-fourths of patients had avoided surgery, radiotherapy and chemotherapy. Longer observation is required to gauge how long responses last and how often cancer returns.
Jemperli can prompt the immune system to attack healthy organs and tissues, with reactions that may prove severe or fatal. The most common side effects, reported in at least 15% of patients, were fatigue, rash, diarrhea and itching. treated for this rectal cancer indication.
Why it matters
This marks the 11th approval under the Commissioner’s National Priority Voucher pilot program. GSK must continue following patients under the accelerated approval to confirm that responses translate into lasting clinical benefit. An earlier Memorial Sloan Kettering study (NCT04165772) of 50 patients found no detectable cancer after Jemperli treatment, and 93% remained cancer-free for at least 12 months. Of the 27 patients followed for at least 3 years, cancer returned in only one. Related Syenza coverage includes dostarlimab organ-preservation in rectal cancer and dostarlimab access in endometrial cancer.
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