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FDA Approves Dostarlimab for dMMR/MSI-H Locally Advanced Rectal Cancer

Published

19 October 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at onclive.com →

◆ Verified

Fusion42 · 19 October 2026 · Fusion42 review

The FDA has granted accelerated approval to dostarlimab for adult patients with stage II or III mismatch repair–deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced rectal cancer, based on strong phase 2 trial results demonstrating sustained clinical complete response and overall response rates.

This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it.

◆ ◆ The Wire takeaway

You can now offer patients with dMMR/MSI-H rectal cancer a new immunotherapy option that may reduce reliance on surgery and radiation. This approval opens a door to personalise treatment and reshape your care approach for this cancer type.

◆ Coverage

5 sources · 19 Oct 2026

◆ Related on Wire

◆ Topics

Biotechfda-approvalimmunotherapyrectal-canceroncologydostarlimabclinical-trials