FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

Regulatory approval: On Oct 8, 2026, the FDA approved atezolizumab (Tecentriq) plus a fluoropyrimidine and oxaliplatin for adjuvant treatment of adult and pediatric patients ≥2 years with resected Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved subcutaneous atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) plus the same chemotherapy for patients ≥12 years and ≥40 kg. Approval was supported by ATOMIC/ML39057 showing improved investigator-assessed DFS (HR 0.50).

FDA approval (Oct 8, 2026)

The US FDA approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients ≥2 years with Stage III mismatch repair deficient (dMMR) colon cancer.

The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) (subcutaneous) with a fluoropyrimidine and oxaliplatin for adults and pediatric patients ≥12 years who weigh ≥40 kg with Stage III dMMR colon cancer. Full prescribing information will be posted on Drugs@FDA.

Supporting evidence

Efficacy and safety were evaluated in ATOMIC/ML39057 (NCT02912559), a multicenter, randomized, open-label, active-controlled trial including 711 adults and 1 pediatric patient with Stage III dMMR colon cancer after complete resection with no evidence of residual lymph node involvement or metastatic disease.

Patients were randomized 1:1 to:

  • Atezolizumab + mFOLFOX6 for 12 cycles, then atezolizumab monotherapy for 6 months, or
  • mFOLFOX6 alone for 12 cycles.

Primary outcome was investigator-assessed disease-free survival (DFS): HR 0.50 (95% CI, 0.35–0.73; p=0.0001); median DFS not reached in either arm.

Key safety information (label warnings/precautions)

Includes immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

The review was conducted under Project Orbis; reviews are ongoing at partner agencies.

Sources