Roche’s Tecentriq has been given FDA Priority Review for adjuvant Tecentriq and Tecentriq Hybreza in combination with chemotherapy for a specific type of stage 3 colon cancer.
The US FDA has accepted the company’s supplemental Biologics License Application (sBLA) filing for stage 3 deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumour characterised by high mutation rates.
Priority Review has been granted and the FDA is expected to make a decision on the approval by 9 October 2026.
Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, said: “This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer.
“The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.”
Michael Sapienza, CEO of Colorectal Cancer Alliance, said: “One in three patients with stage 3 colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options.
“This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumour biology from the very beginning, giving them a better chance of preventing a recurrence.”
The application is based on the landmark ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage 3 dMMR colon cancer, determined by an immunohistochemistry test, such as the VENTANA MMR RxDx Panel.
The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and FOLFOX6.
Colon cancer remains one of the world’s most common and deadliest tumours. Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage 3 patients relapse within five years. Approximately 15% of colon cancer patients present with dMMR/MSI-H tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this first immunotherapy-based adjuvant option to patients with dMMR/MSI-H colon cancer worldwide.