FDA grants Priority Review to Roche’s Tecentriq for a specific form of stage III colon cancer

Roche has confirmed that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), used alongside chemotherapy, in stage III deficient DNA mismatch repair or microsatellite instability-high colon cancer, a tumour type marked by elevated mutation rates. The FDA has granted the application Priority Review status, with a decision anticipated by 9 October 2026.

“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

“One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options,” said Michael Sapienza, CEO, Colorectal Cancer Alliance. “This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence.”

Findings from the pivotal ATOMIC study, published recently in The New England Journal of Medicine, underpin the application. Researchers observed that combining Tecentriq with standard FOLFOX6 chemotherapy lowered the chance of disease coming back or proving fatal by half, when measured against chemotherapy given alone, among people with stage III dMMR colon cancer confirmed via immunohistochemistry methods such as the VENTANA MMR RxDx Panel. At the 36 month mark, 86% of those treated with Tecentriq and FOLFOX6 together remained free of disease, versus 76% in the group receiving FOLFOX6 by itself. Safety findings matched what earlier trials of Tecentriq and FOLFOX6 had already shown.

Among cancers worldwide, colon cancer stands out for both how often it occurs and how frequently it proves fatal. Each year brings over a million new diagnoses across the globe, and despite the combination of surgery and chemotherapy, nearly three in ten people diagnosed at stage III will see their cancer return within five years. Tumours classified as dMMR or MSI-H, distinguished by a higher rate of mutations and a corresponding likelihood of responding well to immunotherapy, are present in around 15% of colon cancer cases.

Beyond the United States, Roche is working through further regulatory channels, among them the European Medicines Agency, in pursuit of making this immunotherapy-based adjuvant treatment, the first of its kind, accessible to patients with dMMR/MSI-H colon cancer everywhere.

Sponsorship for the ATOMIC study came from the National Cancer Institute, with the trial itself led by the Alliance for Clinical Trials in Oncology in conjunction with Roche and Germany’s Arbeitsgemeinschaft Internistische Onkologie group. The work illustrates how Roche continues to partner with prominent academic institutions to address some of oncology’s toughest challenges.

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