SOUTH SAN FRANCISCO, Calif. — October 8, 2026

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient mismatch repair (dMMR) colon cancer. The approval marks the first approved adjuvant immunotherapy-based regimen for this patient population and represents Tecentriq’s 12th indication in the United States.

Phase III ATOMIC Trial Demonstrates Improved Outcomes

The approval is based on results from the Phase III ATOMIC study, which enrolled 712 patients with stage III dMMR colon cancer. Adding Tecentriq to modified FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone. At 36 months, disease-free survival was 86% for patients receiving the combination regimen, compared with 76% for those receiving chemotherapy alone. The findings were published in The New England Journal of Medicine.

Treatment Addresses Unmet Need in dMMR Colon Cancer

Deficient mismatch repair is a tumor characteristic associated with impaired DNA repair and increased mutation rates. Although surgery and chemotherapy are established treatments for stage III colon cancer, recurrence remains a concern, with nearly 30% of patients experiencing a recurrence within five years. The new approval introduces an immunotherapy-based adjuvant option intended to reduce recurrence risk following surgical resection in eligible patients with dMMR disease.

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Tecentriq Expands Its Oncology Portfolio

Tecentriq is a PD-L1 immune checkpoint inhibitor designed to block interactions with PD-1 and B7.1 receptors, helping restore T-cell activity against cancer cells. The FDA decision expands its use across multiple cancer indications and adds an adjuvant treatment option for stage III dMMR colon cancer. The safety profile of Tecentriq combined with modified FOLFOX6 was consistent with previous studies, according to Genentech.

Source::Genentech press release