FDA Approves Atezolizumab Combination for Stage III Colon Cancer

The FDA has approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for adjuvant treatment of Stage III mismatch repair deficient (dMMR) colon cancer, according to an FDA announcement. The approval covers adults and children two years and older, and a subcutaneous formulation, Tecentriq Hybreza, was approved for patients 12 and older weighing at least 40 kg.

This is a confirmed approved therapy, not an investigational compound. Evidence came from the ATOMIC trial, a multicenter, randomized, open label study of 711 adults and one pediatric patient with Stage III dMMR colon cancer following complete tumor resection. Patients received atezolizumab plus mFOLFOX6 chemotherapy for 12 cycles followed by atezolizumab alone, compared to chemotherapy alone. The hazard ratio for disease free survival was 0.50, meaning roughly half the risk of recurrence or death in the atezolizumab arm, with median disease free survival not yet reached in either group.

The prescribing information carries warnings for immune mediated adverse reactions, infusion reactions, complications with stem cell transplantation, and embryo fetal toxicity. The review was conducted through Project Orbis, an international collaboration involving regulators in Australia, Canada, Israel, and Switzerland, with those reviews still ongoing.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.