Wire · operational-macro
FDA Grants Accelerated Approval to Dostarlimab for dMMR Rectal Cancer
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Fusion42 · 19 October 2026 · Fusion42 review
The FDA granted accelerated approval to dostarlimab-gxly (Jemperli; GSK) as monotherapy for adults with dMMR or MSI-H locally advanced rectal cancer, potentially allowing some patients to avoid chemotherapy, radiation, and surgery based on promising interim phase 2 AZUR-1 results.
This Wire brief sits within Fusion42's coverage of Biotech, and 7 sources have reported it.
◆ ◆ The Wire takeaway
You can now pivot to offering immunotherapy-based regimens that avoid surgery and radiation for certain rectal cancer patients. This approval opens a faster path to market for treatments targeting dMMR or MSI-H cancers.
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7 sources · 19 Oct 2026
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