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The FDA granted accelerated approval for Jemperli (dostarlimab-gxly) alone in adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are dMMR or MSI-H. In interim results from a 154-person study, nearly three-fourths had not needed surgery, radiation or chemotherapy after a median follow-up of more than two years. Further follow-up is required to confirm lasting benefit and track recurrence.
The U.S. Food and Drug Administration on October 19, 2026, granted accelerated approval for Jemperli (dostarlimab-gxly) alone for some adults with previously untreated stage II or III locally advanced rectal cancer. Eligibility is limited to tumors that test mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H); the treatment may help some patients avoid chemotherapy, radiation and surgery, but lasting benefit still must be confirmed.
The approval covers adults with stage II or stage III disease that has grown into nearby tissue or reached nearby lymph nodes, but has not spread to distant organs. Patients’ tumors must be identified as dMMR or MSI-H by an FDA-authorized test. The FDA said published estimates suggest these tumor features occur in about 3% of locally advanced rectal cancers, so the new use applies to a small, defined group rather than all rectal cancer patients.
The decision relied on interim findings from AZUR-1, a phase 2 study of 154 patients with previously untreated dMMR or MSI-H locally advanced rectal cancer. Participants received up to nine doses of Jemperli, administered every three weeks over six months. After a median follow-up of more than two years, almost three-fourths had not needed surgery, radiotherapy or chemotherapy, according to the FDA. The agency said longer monitoring is needed to determine how durable the responses are and how often cancer returns.
The FDA also cited an earlier, separate study at Memorial Sloan Kettering Cancer Center involving 50 patients with the same tumor characteristics. The agency reported that none had detectable signs of cancer after treatment and that 93% maintained that status for at least 12 months. Among the 27 patients followed for at least three years, one had a recurrence in the same area. These findings come from a separate study and do not replace the need for continued follow-up of AZUR-1.
A New Option to Avoid Standard Treatment
For eligible patients, the approval offers a treatment path that may avoid interventions commonly used before surgery for locally advanced rectal cancer. The FDA says chemotherapy and radiation can have lasting effects on bowel, urinary and sexual function, as well as fertility. Surgery can bring serious complications, including poor healing or leaks where the bowel is reconnected; some patients may require a permanent colostomy.
The approval does not establish that every eligible patient can safely forgo those treatments. Instead, it makes Jemperli available as a potential alternative for a biomarker-selected group, with decisions about care requiring discussion between patients and their cancer teams. Because the authorization is accelerated and rests on interim results, durability and recurrence remain central questions for regulators and clinicians.
Jemperli blocks PD-1, a protein on immune cells that cancer cells can use to evade immune attack. The FDA warns that the drug can also prompt the immune system to attack healthy organs and tissues, sometimes severely or fatally. Common reported side effects in this rectal cancer setting included fatigue, rash, diarrhea and itching.
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Why Tumor Testing Defines Eligibility
The terms dMMR and MSI-H describe related signs that a tumor’s DNA error-correction system is not working properly. When errors accumulate, they can produce proteins the immune system may recognize, making these cancers more susceptible to immunotherapy, according to the FDA. A patient’s stage alone is not enough to qualify: the tumor must also meet the specified biomarker criteria through an FDA-authorized test.
Many patients with locally advanced rectal cancer receive chemotherapy and radiation before surgery. The FDA described this sequence as standard treatment for many patients, while the new approval targets a narrower subgroup. The earlier Memorial Sloan Kettering study provided supportive evidence, while the agency’s decision was based on interim AZUR-1 results.
The FDA granted the application Priority Review and designated Jemperli a Breakthrough Therapy for this use. The agency said the decision was its 11th drug approval reviewed under the Commissioner’s National Priority Voucher pilot program. FDA Acting Commissioner Kyle Diamantas said the review was completed nearly four months ahead of schedule; the accelerated timeline does not change the requirement for further evidence of clinical benefit.
“Completing this review nearly 4 months ahead of schedule means some patients who might otherwise be preparing for surgery, radiation or chemotherapy may now have a different conversation with their doctor.”
— Kyle Diamantas, J.D., acting FDA commissioner
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Durability and Recurrence Still Under Review
The FDA granted accelerated approval based on interim trial results. GSK, the approval holder, must continue following study participants to provide evidence that the observed responses lead to lasting clinical benefit. The agency said the available AZUR-1 follow-up is not yet enough to establish how long responses last or how often disease returns.
The reported result that almost three-fourths had not needed surgery, radiation or chemotherapy is a finding at the available follow-up point; it does not show that those treatments will never be needed. The FDA announcement does not specify how the result may change with longer observation. It also does not provide a full comparison against standard treatment or establish the best approach for patients outside the approved biomarker and stage criteria.
Jemperli carries risks of immune reactions affecting healthy organs and tissues, which can be severe or fatal. The announcement lists common side effects but does not provide individualized risk estimates for each patient. Patients and clinicians will need to weigh the potential to avoid other treatments against the drug’s risks and the remaining uncertainty about long-term outcomes.
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Further Follow-Up Will Test Benefit
GSK must continue monitoring patients in the clinical evidence supporting accelerated approval and submit further data to confirm lasting clinical benefit. Longer follow-up should help clarify response duration and recurrence rates, including whether patients who initially avoid other treatments later require them.
For people considering this option, the immediate next step is to confirm whether the tumor meets the dMMR or MSI-H criteria with an FDA-authorized test and discuss treatment choices with their oncology team. The FDA’s announcement does not set out an individual treatment plan or say that conventional therapies should be withheld in every eligible case.
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Key Questions
Who is eligible for the new Jemperli use?
The FDA approval is for adults with previously untreated stage II or III locally advanced rectal cancer whose tumors test dMMR or MSI-H using an FDA-authorized test. It does not apply to all patients with rectal cancer.
Does the approval mean patients can definitely avoid surgery and other treatment?
No. Interim AZUR-1 results found that almost three-fourths of participants had not needed surgery, radiation or chemotherapy after a median follow-up of more than two years. The result does not guarantee that an individual patient will avoid those treatments or never need them later.
What does accelerated approval mean here?
The FDA approved the use based on interim evidence, while requiring further study to confirm lasting clinical benefit. GSK must continue following patients and provide additional evidence.
What side effects did the FDA report?
Common reported side effects included fatigue, rash, diarrhea and itching. The FDA also warns that Jemperli can cause the immune system to attack healthy organs and tissues, with reactions that may be severe or fatal.
Source: primary
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