FDA Grants Priority Review to Dostarlimab for dMMR/MSI-H Locally Advanced Rectal Cancer

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 4 sources have reported it between 24 Aug 2026 and 25 Aug 2026.