Roche Wins FDA Nod for Tecentriq in Stage III dMMR Colon Cancer

The U.S. Food and Drug Administration (FDA) approved Roche’s Tecentriq (atezolizumab) with chemotherapy as adjuvant treatment after surgery for Stage III colon cancer with deficient mismatch repair (dMMR). It is the first immunotherapy-based regimen approved for this setting and Tecentriq’s 12th U.S. indication.

The approval is based on the Phase III ATOMIC study. Adding Tecentriq to standard chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone.

At three years, disease-free survival was 86% with the Tecentriq combination and 76% with chemotherapy alone. The regimen is positioned to become a new standard of care for this patient population.