FDA approves GSK's Jemperli for a specific rectal cancer type

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Go back to FDA approves GSK's Jemperli for a specific rectal cancer type

Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer

October 19, 2026 6:18 PM EDT

Approval based on AZUR-1 data showing clinically significant proportion of participants with no detectable signs of cancer one year or more after treatment No disease recurrences reported among responders after median follow up of more than two years Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high... More