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Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally ...
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Fusion42 · 24 August 2026 · Fusion42 review
The US FDA has accepted for priority review the supplemental Biologics License Application for Jemperli (dostarlimab) to treat dMMR/MSI-H locally advanced rectal cancer, with a PDUFA date in February 2027. Jemperli has the potential to reduce or eliminate the need for chemotherapy, radiation, and surgery for some patients, based on positive phase II trial data.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.
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You can prepare for earlier market access shifts in immunotherapy for rectal cancer as the FDA prioritises Jemperli's review. Competing founders should reassess their differentiation and timing in advanced colorectal treatments.
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3 sources · 24 Aug 2026
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