FDA Grants Accelerated Approval to Dostarlimab for Locally Advanced Rectal Cancer
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On October 19, 2026, the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) as a single-agent treatment for adults with previously untreated mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) stage II or III locally advanced rectal cancer. The decision was based on single-arm trial data and positions the immunotherapy as an option that may allow certain patients to avoid chemotherapy, radiation and surgery. Accelerated approval means confirmatory evidence of clinical benefit is still required, so the magnitude and durability of outcomes remain open questions. How widely the approach is adopted in practice, and whether full approval follows, has yet to be determined.
Written by a model from the reports · updated 2 hours ago
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- U.S. FDAFDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
On October 19, the FDA granted accelerated approval to Jemperli (dostarlimab-gxly) as a single agent for adults with previously untreated dMMR or MSI-H stage II or III locally advanced rectal cancer.
- U.S. FDAPickFDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
On October 19, 2026, the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with previously untreated, MSI-H or dMMR Stage II/III locally advanced rectal cancer, based on single-arm trial data.
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