FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer
On October 8, 2026, the FDA approved atezolizumab with a fluoropyrimidine and oxaliplatin for adjuvant treatment of Stage III dMMR colon cancer. The FDA said the ATOMIC trial showed a hazard ratio of 0.50 for disease-free survival.
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On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for the same use in patients 12 years of age and older who weigh 40 kg or greater.
What the FDA approved
The FDA page lists two products. Tecentriq is given intravenously. Tecentriq Hybreza is a subcutaneous injection that combines atezolizumab with hyaluronidase.
The approved use is adjuvant treatment, which means treatment given after the primary tumor has been removed. Both products are approved in combination with a fluoropyrimidine and oxaliplatin.
The FDA said the recommended atezolizumab dose for adult patients is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks, given intravenously with chemotherapy for six months. Atezolizumab then continues as a single agent for six months or until disease recurrence or unacceptable toxicity.
For pediatric patients, the FDA said the recommended dose is 10 mg/kg (up to a maximum of 840 mg) every two weeks or 15 mg/kg (up to a maximum of 1200 mg) every three weeks. The same chemotherapy period and single-agent period apply.
The recommended dosage of atezolizumab and hyaluronidase-tqjs is one 15 mL injection every three weeks. Each injection contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase. The FDA said the dosage for pediatric patients under 12 years of age, and for patients 12 years of age and older who weigh less than 40 kg, has not been established.
The trial behind the approval
The FDA said efficacy was evaluated in ATOMIC/ML39057 (NCT02912559). The agency described it as a multicenter, randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with Stage III dMMR colon cancer. All patients had a complete resection of the primary tumor, with no evidence of residual lymph node involvement or metastatic disease.
Patients were randomized 1:1. One arm received atezolizumab with mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) for 12 cycles, followed by atezolizumab monotherapy for 6 months. The other arm received mFOLFOX6 alone for 12 cycles.
The major efficacy outcome measure was disease-free survival (DFS) as assessed by the investigator. The FDA said the hazard ratio for the DFS comparison was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001). The FDA also said the median DFS was not reached in either arm.
The registry record for NCT02912559 lists the National Cancer Institute (NCI) as the lead sponsor. The record describes a Phase III, randomized, parallel assignment study with 712 participants. It lists the start date as October 16, 2017 and primary completion as 2025-02-04. The overall status is active, not recruiting.
According to the registry record, the primary outcome is disease-free survival at 3 years. The record lists overall survival and adverse events, measured with the Common Terminology Criteria for Adverse Events, as secondary outcomes. In the record, the experimental arm receives FOLFOX chemotherapy for up to 12 cycles plus atezolizumab for up to 25 cycles, and the comparator arm receives FOLFOX chemotherapy alone for up to 12 cycles.
Safety information in the label
The FDA said the prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem-cell transplantation, and embryo-fetal toxicity. The agency said full prescribing information for Tecentriq and Tecentriq Hybreza will be posted on Drugs@FDA.
Review details and what comes next
The FDA said it conducted the review under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), Israel's Ministry of Health (ImoH), and Switzerland's Swissmedic. The FDA said the application reviews are ongoing at the other regulatory agencies.
The FDA also said the review used the Assessment Aid, a voluntary submission from the applicant to support the FDA's assessment. The applications were granted priority review.
The FDA page does not state a launch date or a price for either product. The registry record gives an estimated final completion date of 2026-12-18 for the trial.
Sources
- FDA: FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer (October 8, 2026)
- ClinicalTrials.gov: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT02912559)