The FDA granted Priority Review for Roche’s Tecentriq in combination with chemotherapy for stage III colon cancer. The application targets patients with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) tumors following surgery. The agency expects to reach an approval decision by October 9, 2026.
Data from the Phase III ATOMIC study showed the combination reduced the risk of cancer recurrence or death by 50%. The combination maintained an 86% disease-free rate after three years. This compares to a 76% disease-free rate for those on chemotherapy alone.
If approved, Tecentriq would become the first immunotherapy-based adjuvant treatment option for this specific patient population.