News / 20 October 2026

FDA grants accelerated approval to Jemperli for certain locally advanced rectal cancers

20 October 2026 · Based on: U.S. Food and Drug Administration

The FDA granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally advanced rectal cancer to avoid common treatments.^[1] Acting FDA Commissioner Kyle Diamantas said the review was completed nearly 4 months ahead of schedule.^[1]

The approval covers Jemperli used alone in adults with previously untreated stage II or stage III locally advanced rectal cancer.^[1] Tumours must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), as determined by an FDA-authorized test.^[1] Published estimates suggest that approximately 3% of locally advanced rectal cancers are dMMR or MSI-H.^[1]

The FDA based its decision on interim results from AZUR-1, a phase 2 study evaluating Jemperli alone in 154 patients with previously untreated dMMR or MSI-H locally advanced rectal cancer.^[1] Patients received up to nine doses, given every 3 weeks over 6 months.^[1] After a median follow-up of more than 2 years, almost three-fourths of patients had not needed surgery, radiotherapy or chemotherapy.^[1] The FDA states that longer follow-up is needed to understand the duration of response and how often the cancer returns.^[1]

An earlier study at Memorial Sloan Kettering Cancer Center evaluated Jemperli alone in 50 patients with the same type of rectal cancer.^[1] None of the patients had detectable signs of cancer after treatment, and 93% maintained that cancer-free status for at least 12 months.^[1] Of the 27 patients followed for at least 3 years, only one had their cancer return, and it recurred in the same area.^[1]

Jemperli can cause the immune system to attack healthy organs and tissues, and these reactions can be severe or fatal.^[1] The most common side effects, reported in at least 15% of patients treated for this type of rectal cancer, were fatigue, rash, diarrhea and itching.^[1] The FDA granted Priority Review to the application and Breakthrough Therapy designation to Jemperli for dMMR or MSI-H locally advanced rectal cancer.^[1] Because this is an accelerated approval based on interim trial results, the sponsor must continue following patients to show these responses create lasting clinical benefit.^[1]

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