BASEL, Switzerland — October 9, 2026

Roche (SIX: RO, ROP; OTCQX: RHHBY) 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 immunotherapy-based adjuvant regimen approved for this patient population and the twelfth U.S. indication for Tecentriq. The decision provides a new treatment option for patients at risk of cancer recurrence following surgery.

ATOMIC Trial Demonstrates 50% Reduction in Recurrence Risk

The approval is based on findings from the Phase 3 ATOMIC study, which evaluated Tecentriq in combination with modified FOLFOX6 chemotherapy against chemotherapy alone in 712 patients with stage III dMMR colon cancer. Adding Tecentriq reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone. At 36 months, disease-free survival was 86% in the combination group, compared with 76% in the chemotherapy-only group. The study’s findings were published in The New England Journal of Medicine, supporting the clinical evidence behind the FDA decision.

Combination Regimen Addresses High Recurrence Risk

Stage III colon cancer carries a substantial risk of recurrence despite surgery and chemotherapy, with nearly 30% of patients experiencing a recurrence within five years. The dMMR subtype is characterized by defects in the DNA mismatch repair system, which can result in increased tumour mutation rates and may make cancers more responsive to immunotherapy. In the ATOMIC study, patients receiving Tecentriq plus mFOLFOX6 underwent 12 cycles of chemotherapy over six months, followed by Tecentriq monotherapy for an additional six months. Roche reported that the safety profile of the combination was consistent with previous studies of Tecentriq and mFOLFOX6.

Advertisement

cGxPJobs Banner

Roche Pursues Broader Global Access

The FDA approval expands Tecentriq’s role in oncology and advances the use of immunotherapy earlier in the treatment pathway for selected patients with colon cancer. Roche is pursuing additional regulatory filings, including with the European Medicines Agency, to expand access to the regimen internationally. Tecentriq is a monoclonal antibody that targets PD-L1, a protein involved in suppressing immune responses against tumours. By blocking PD-L1 interactions with PD-1 and B7.1 receptors, the medicine is designed to help restore T-cell activity against cancer cells. The newly approved regimen offers an additional post-surgical treatment approach for patients with stage III dMMR colon cancer.

Source::Roche, press release