FDA Approves Roche's Tecentriq as Adjuvant Therapy for Stage III dMMR Colon Cancer
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On October 8, 2026, the US FDA approved Roche's atezolizumab (Tecentriq), given intravenously with fluoropyrimidine and oxaliplatin chemotherapy, as post-surgery adjuvant treatment for stage III mismatch repair-deficient (dMMR) colon cancer in adults and children aged 2 and older. The subcutaneous formulation Tecentriq Hybreza, atezolizumab with hyaluronidase-tqjs, was approved with the same chemotherapy for patients aged 12 or older weighing at least 40 kg. Roche calls it the first immunotherapy adjuvant approval for this disease in the US. The ATOMIC trial of 711 adults and one pediatric patient showed a 50% reduction in risk of disease recurrence or death versus mFOLFOX6 alone. These are Tecentriq's second US indication expansions this year, following an earlier approval for Signaterg ctDNA-positive muscle-invasive bladder cancer. Reviews are ongoing at partner agencies under Project Orbis.
Written by a model from the reports · updated 3 days ago
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- mp.weixin.qq.comFDA Approves Roche's Tecentriq as Adjuvant Therapy for Stage III dMMR Colon Cancer
The US FDA has approved Roche's Tecentriq (atezolizumab) and its subcutaneous formulation Tecentriq Hybreza (atezolizumab and hyaluronidase), each combined with fluoropyrimidine and oxaliplatin, as post-surgery adjuvant treatment for stage III mismatch repair-deficient (dMMR) colon cancer. Roche said this is the first immunotherapy adjuvant approval for stage III dMMR colon cancer in the US, based on data showing a 50% reduction in risk of disease recurrence or death.
- mp.weixin.qq.comFDA Approves IV and Subcutaneous Tecentriq for Stage III dMMR Colon Cancer Adjuvant Therapy
On October 8, 2026, the FDA approved Genentech/Roche's atezolizumab (Tecentriq), given intravenously with fluoropyrimidine plus oxaliplatin chemotherapy, as adjuvant treatment after surgery for stage III mismatch repair-deficient (dMMR) colon cancer in adults and children aged 2 and older. The subcutaneous formulation Tecentriq Hybreza, atezolizumab with hyaluronidase-tqjs, was also approved with the same chemotherapy for patients aged 12 or older weighing at least 40 kg. These are Tecentriq's second US indication expansions this year, after its approval months earlier for Signatera ctDNA-positive muscle-invasive bladder cancer.
- fda.govPickFDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer
The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.
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