FDA grants accelerated approval to GSK's Jemperli for MSI-H/dMMR rectal cancer
The FDA approved GSK's Jemperli as the first immunotherapy for adults with locally advanced MSI-H/dMMR rectal cancer, under the accelerated pathway.
- published on Newsmetry
- original source published
the public page opens no earlier than 15 minutes after we detect the story. approved stories may reach the api sooner. connect the api →
what happened
The US Food and Drug Administration has given accelerated approval to GSK plc's Jemperli (dostarlimab-gxly) for adults with stage II and III locally advanced rectal cancer that is MSI-H or dMMR, according to GSK. The company calls it the first and only immunotherapy for this group. The biomarker is found in roughly 5-10% of rectal cancers.
Current treatment combines chemotherapy, radiation and surgery, which can cause lasting side effects. In the phase II AZUR-1 trial, 68% of evaluable patients reached a sustained clinical complete response at 12 months without surgery. The most common adverse reactions were fatigue, rash, diarrhea and pruritus.
why it matters
The news is relevant mainly to the pharmaceutical sector and has limited effect on the broad market. For GSK investors it expands the oncology portfolio, though revenue impact from one indication is likely modest.
market impact
Pharma: the approval widens Jemperli's indications for GSK, with a moderate effect on the company's shares
tags
instruments
sources
- Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer — TradingView, 19 October 2026 at 22:18 UTC
- Jemperli (Dostarlimab-Gxly) Approved In Us As First And Only Immunotherapy For Adults With Msi-H/Dmmr Locally Advanced Rectal Cancer — Reuters, 19 October 2026 at 22:30 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
the public page opens no earlier than 15 minutes after we detect the story. approved stories may reach the api sooner.
get stories in real time ↗