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Tecentriq

FDA Grants Priority Review for Roche's Tecentriq in Stage III dMMR Colon Cancer After Surgery

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FDA Grants Priority Review for Roche's Tecentriq in Stage III dMMR Colon Cancer After Surgery

SHERIDAN, WYOMING -- June 15, 2026 -- The U.S. Food and Drug Administration has accepted Roche's supplemental Biologics License Application for Tecentriq and Tecentriq Hybreza in combination with chemotherapy as an adjuvant treatment for stage III dMMR/MSI-H colon cancer following surgery. The FDA has granted Priority Review and is expected to issue a decision by October 9, 2026. The filing is supported by Phase III ATOMIC study data showing a 50% reduction in the risk of disease recurrence or death compared to chemotherapy alone, results published in The New England Journal of Medicine.