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  6. FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer
  1. Resources for Information | Approved Drugs

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

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.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer.

Full prescribing information for Tecentriq and Tecentriq Hybreza will be posted on Drugs@FDA .

Efficacy and Safety

Efficacy was evaluated in ATOMIC/ML39057 (NCT02912559), a multicenter, randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with Stage III dMMR colon cancer after a complete resection of the primary tumor with no evidence of residual lymph node involvement or metastatic disease. Patients were randomized (1:1) to receive either atezolizumab in combination with mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) for 12 cycles followed by atezolizumab monotherapy for 6 months, or mFOLFOX6 alone for 12 cycles.

The major efficacy outcome measure was disease-free survival (DFS) as assessed by the investigator. The hazard ratio for the DFS comparison was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), and the median DFS was not reached (NR) in either arm.

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.

Recommended Dosage

The recommended atezolizumab dose for adult patients is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks administered intravenously in combination with chemotherapy for six months, followed by atezolizumab as a single agent for six months or until disease recurrence or unacceptable toxicity. The recommended dose for pediatric patients 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 in combination with chemotherapy for six months, followed by atezolizumab as a single agent for six months or until disease recurrence or unacceptable toxicity, whichever occurs first.

The recommended dosage of atezolizumab and hyaluronidase-tqjs in adults and pediatric patients 12 years of age and older who weigh 40 kg or greater is one 15 mL injection every three weeks (containing 1875 mg of atezolizumab and 30,000 units of hyaluronidase) administered subcutaneously in combination with chemotherapy for six months, followed by atezolizumab and hyaluronidase-tqjs as monotherapy for six months or until disease recurrence or unacceptable toxicity, whichever occurs first. The recommended dosage for pediatric patients under 12 years of age and patients 12 years of age and older who weigh less than 40 kg has not been established.

This review was conducted 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, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), Israel’s Ministry of Health (ImoH), and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

These applications were granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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