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FDA Grants Priority Review to Dostarlimab for dMMR/MSI-H Locally Advanced Rectal Cancer
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Fusion42 · 25 August 2026 · Fusion42 review
The FDA has granted priority review to dostarlimab for treatment of previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer with a target action date of February 2027, based on promising phase 2 AZUR-1 trial results demonstrating sustained clinical complete responses.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.
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You need to prepare your development plans around the February 2027 FDA decision that could open US market access for dostarlimab in rectal cancer. Regulatory precedence here signals faster launch paths for novel immunotherapies targeting rare genetic cancer subtypes.
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3 sources · 24 Aug 2026
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