Dostarlimab Receives FDA Accelerated Approval for MSI-H/dMMR Locally Advanced Rectal Cancer

The FDA granted accelerated approval to dostarlimab for adults with stage II or III MSI-H/dMMR locally advanced rectal cancer, marking the first immunotherapy approved to potentially allow eligible patients to avoid chemotherapy, radiation, and surgery. The approval is based on positive interim phase 2 trial results showing a high rate of sustained clinical complete response with a manageable safety profile.

This Wire brief sits within Fusion42's coverage of Biotech, and 9 sources have reported it.