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GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer
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Fusion42 · 21 October 2026 · Fusion42 review
GSK’s immunotherapy drug Jemperli (dostarlimab), initially approved for endometrial cancer, has received accelerated FDA approval for treating locally advanced stage II and III rectal cancer with MSI-H or dMMR genetic profiles, offering an alternative to chemotherapy, radiation, and surgery. The approval is based on pivotal Phase 2 trial data showing durable responses, and ongoing trials are exploring further cancer indications.
This Wire brief sits within Fusion42's coverage of Biotech, and 15 sources have reported it between 19 Oct 2026 and 25 Oct 2026.
◆ ◆ The Wire takeaway
You now have a new regulatory path to replace chemo and surgery for some rectal cancer patients using Jemperli. This opens a patient base that was previously locked to aggressive treatments and demands investment in MSI-H/dMMR testing services.
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15 sources · first reported 19 Oct 2026 · latest 25 Oct 2026
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