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# FDA OKs Tecentriq with Chemotherapy for Stage III Colon Cancer
- URL: https://www.fdaweb.com/fda-oks-tecentriq-with-chemotherapy-for-stage-iii-colon-cancer/
- Published: 2026-10-08T20:13:04.000Z
- Updated: 2026-10-08T20:13:04.000Z
- Author: David McFarland
- Tags: Biologics

FDA has approved Genentech’s Tecentriq (atezolizumab) for combination use 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 agency also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) 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.

Approval was based on data from the 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, FDA says. Patients were randomized 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 agency says. “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 FDA-approved 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.