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FDA Approves Adjuvant Atezolizumab for Certain Colon Cancers
The approval is based on the Phase III ATOMIC trial, which found a 50% lower risk of recurrence or death and 86% 36-month disease-free survival.
- On Friday, October 9, 2026, the U.S. Food and Drug Administration approved Genentech's Tecentriq and Tecentriq Hybreza combined with chemotherapy for adjuvant treatment of stage III deficient DNA mismatch repair colon cancer.
- Data from the Phase III ATOMIC study demonstrated that adding Tecentriq to chemotherapy reduced the risk of disease recurrence or death by 50%, with 36-month disease-free survival reaching 86% compared to 76% for chemotherapy alone.
- Approximately 15% of colon cancer patients present with dMMR tumors. Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, stated, "This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence."
- "Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status," said Frank A. Sinicrope, M.D., professor of oncology at the Mayo Clinic and U.S. principal investigator for the Alliance ATOMIC trial.
- Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years. Genentech, founded 50 years ago, designed this immunotherapy to target these tumors and improve long-term clinical outcomes.
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FDA approves atezolizumab combination for stage III colon cancer with deficient DNA mismatch repair
The Alliance for Clinical Trials in Oncology (Alliance) today announced that the U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq) in combination with fluoropyrimidine and oxaliplatin chemotherapy, for the adjuvant treatment of patients with stage III colon cancer with deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR).
·Mona Vale, Australia
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FDA Approves Adjuvant Atezolizumab for Certain Colon Cancers
(MedPage Today) -- The FDA on Thursday approved intravenous atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III mismatch repair-deficient (dMMR) colon cancer in patients 2 years...
·New York, United States
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R 17%
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