FDA approves Roche's Tecentriq for stage III colon cancer

The US Food and Drug Administration approved Roche's Tecentriq and Tecentriq Hybreza in combination with chemotherapy for the adjuvant treatment of stage III deficient DNA mismatch repair colon cancer on October 9, 2026. The therapy pairs with a fluoropyrimidine and oxaliplatin, marking the twelfth US indication for Tecentriq.

The regulatory decision is based on data from the phase III ATOMIC study, which enrolled 712 patients and was published in The New England Journal of Medicine. Adding Tecentriq to modified FOLFOX6 chemotherapy cut the risk of disease recurrence or death by 50% compared to chemotherapy alone.

In the trial, 36-month disease-free survival reached 86% for patients receiving Tecentriq with mFOLFOX6, compared with 76% for those on chemotherapy alone. The safety profile remained consistent with earlier studies of the combination.

More than one million people receive a colon cancer diagnosis worldwide each year, and nearly 25% of cases are diagnosed at stage III. Approximately 15% of patients feature deficient DNA mismatch repair or microsatellite instability-high tumours, while nearly 30% of stage III patients face disease recurrence within five years. Roche announced it is also seeking regulatory approval with the European Medicines Agency.