The U.S. Food and Drug Administration on Monday granted accelerated approval to GSK plc for Jemperli (dostarlimab-gxly). Jemperli is the first and only immunotherapy for adults with stage II and III mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced rectal cancer. The decision allows eligible patients to bypass traditional treatments that permanently affect daily life. Jemperli monotherapy offers a less invasive alternative for the 3% to 10% of rectal cancer patients whose tumors have the dMMR or MSI-H biomarker.
Patients with locally advanced rectal cancer have historically received chemotherapy and radiation before surgery. These treatments frequently cause severe complications, including infertility, secondary cancers, and bowel, urinary and sexual dysfunction. Surgery also carries risks of life-threatening complications or a permanent colostomy.
The dMMR and MSI-H terms identify a defect in how cancer cells repair DNA errors. Accumulating errors allow the immune system to recognize abnormal proteins. Jemperli blocks the PD-1 protein on immune cells, preventing cancer cells from using PD-1 to evade immune detection.
The FDA based the approval on the Phase II AZUR-1 clinical trial. The trial treated 154 patients with Jemperli every three weeks for six months. Nearly 75% of participants avoided surgery, chemotherapy and radiotherapy entirely after median follow-up exceeding two years. Investigator assessments found that 68% of evaluable participants sustained a complete clinical response at 12 months. Independent central reviews found that 47% achieved this response, with data still maturing.
An earlier trial at Memorial Sloan Kettering Cancer Center observed 50 patients and found no detectable signs of cancer after treatment. The earlier trial found that 93% maintained this status for at least 12 months. GSK plans to present the complete interim AZUR-1 data at the European Society for Medical Oncology Congress in October 2026.
Benzinga Pro data showed GSK shares up 0.32% at $49.67 at the time of publication on Monday.
FDA Approves GSK's Jemperli for Treating Certain Rectal Cancers
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Summary
The FDA approved GSK’s Jemperli for certain rectal cancers, marking a shift in treatment options. This immunotherapy offers an alternative to chemo and radiation, with 75% of trial participants avoiding surgery after six months. As altcoins to watch gain attention, biotech news like this can influence the fear and greed index. GSK will share full data at the ESMO Congress in 2026.
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