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FDA approves Jemperli as first immunotherapy for MSI-H/dMMR locally advanced rectal cancer
GLAXFGSK plc
The US FDA has approved Jemperli (dostarlimab) under the accelerated approval pathway as the first and only immunotherapy for adults with stage II and III microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer. The approval is based on AZUR-1 trial data showing a 68% sustained clinical complete response rate at 12 months, with no disease recurrences reported among responders after more than two years of follow-up. This monotherapy offers eligible patients the potential to avoid chemotherapy, radiation, and surgery. GSK plc operates as a global biopharmaceutical company focused on vaccines, specialty medicines, and consumer healthcare.