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News
The FDA has approved atezolizumab (Tecentriq) combined with fluoropyrimidine and oxaliplatin as adjuvant treatment for stage III mismatch repair–deficient (dMMR) colon cancer in adults and children aged 2+. A subcutaneous formulation (Tecentriq Hybreza) was also approved for eligible patients. The decision was backed by the phase 3 ATOMIC trial, which showed a 50% reduction in the risk of disease recurrence compared to chemotherapy alone.
The FDA has approved atezolizumab (Tecentriq, Genentech) in combination with fluoropyrimidine and oxaliplatin as adjuvant treatment for adult and pediatric patients aged 2 and older with stage III mismatch repair–deficient (dMMR) colon cancer. A subcutaneous formulation — atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) — was simultaneously approved for adults and children aged 12+ weighing at least 40 kg with the same indication.
The approval was based on the phase 3 ATOMIC/ML39057 trial, which enrolled 711 adult patients and one pediatric patient with completely resected stage III dMMR colon cancer. Patients received either atezolizumab plus mFOLFOX6 for 12 cycles followed by atezolizumab monotherapy, or mFOLFOX6 alone. The combination arm demonstrated a meaningful improvement in disease-free survival, cutting the risk of recurrence in half.
By the Numbers:
Why it matters: dMMR colon cancer is a molecularly distinct subtype with limited adjuvant options. This approval adds a powerful immunotherapy-based regimen to the toolkit, potentially preventing recurrence in a population that historically faces high relapse risk after surgery.
