FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

Overview

• Roche announced that the FDA accepted its supplemental biologics licence application for adjuvant Tecentriq and granted Priority Review, with a decision expected by October 9, 2026, after the company filed the submission on June 11, 2026.
• The submission is built on the phase III ATOMIC trial, which enrolled 712 patients and used disease-free survival as its primary endpoint.
• ATOMIC showed that adding atezolizumab to standard FOLFOX6 chemotherapy cut the risk of recurrence or death by about 50% and raised three-year disease-free survival to roughly 86% versus 76% with chemotherapy alone.
• The sBLA targets patients whose tumours are deficient in DNA mismatch repair or are microsatellite instability-high, a biomarker seen in about 15% of colon cancers that signals higher mutation burden and greater likelihood of response to immunotherapy.
• Trial investigators and Roche say the safety profile matched prior experience, the NCCN has begun to reflect ATOMIC findings, and Roche plans further regulatory filings, including with the European Medicines Agency, which could change adjuvant care options for this biomarker-defined group worldwide.