FDA Approves GSK's Jemperli for MSI-H/dMMR Locally Advanced Rectal Cancer
The US FDA approved GSK's Jemperli as the first immunotherapy for adults with stage II and III MSI-H/dMMR rectal cancer, Reuters reported.
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what happened
The US Food and Drug Administration has granted accelerated approval to GSK's Jemperli (dostarlimab). It is the first and only immunotherapy for adults with stage II and III locally advanced rectal cancer that is MSI-H or dMMR, a biomarker found in roughly 5-10% of rectal cancers.
In the phase II AZUR-1 trial, investigators assessed 68% of evaluable patients (98 of 144) as reaching a clinical complete response sustained for 12 months. Under independent central review, the figure was 47% (54 of 116). No recurrences had been reported among responders after a median follow-up of more than two years. Serious adverse reactions occurred in 20% of patients.
why it matters
For GSK, the approval extends its colorectal and broader oncology portfolio into a niche patient group. Full AZUR-1 data are due at the ESMO Congress in October 2026, which investors will likely watch. The eligible population is small, so the near-term revenue effect is likely limited.
market impact
GSK shares: the approval widens its oncology portfolio, supporting investor interest in the franchise
tags
instruments
sources
- REG - GSK PLC - Jemperli approved in MSI-H/dMMR rectal cancer — Reuters, 19 October 2026 at 16:21 UTC
- FDA Approves GSK's Jemperli As First Immunotherapy For MSI-H/DMMR Rectal Cancer — Reuters, 19 October 2026 at 16:27 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
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