Genentech has received FDA Priority Review for Tecentriq in stage III colon cancer. The FDA Priority Review covers supplemental applications for Tecentriq and Tecentriq Hybreza. Moreover, the FDA Priority Review advances a potential treatment option for eligible patients.
The therapies will be used with chemotherapy for patients with stage III deficient DNA mismatch repair or microsatellite instability-high (MSI-H) colon cancer. These tumors typically have high mutation rates. In addition, the FDA granted Priority Review for the application. The agency is expected to issue its approval decision by October 9, 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, M.D., Ph.D., 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.”
ATOMIC Study Supports FDA Filing
The application is based on findings from the landmark ATOMIC study. Recently, The New England Journal of Medicine published the study results. The ATOMIC trial showed that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%. The comparison was made against chemotherapy alone in patients with stage III dMMR colon cancer. Researchers identified eligible patients through immunohistochemistry testing. Testing methods included tools such as the VENTANA MMR RxDx Panel. Also the study reported strong disease-free survival outcomes. The 36-month disease-free survival rate reached 86% for patients receiving Tecentriq and FOLFOX6. Meanwhile, patients receiving FOLFOX6 alone achieved a 76% survival rate.
The safety profile remained consistent with previous Tecentriq and FOLFOX6 studies. Therefore, the findings reinforced confidence in the treatment approach. Colon cancer remains one of the most common and deadly cancers worldwide. Each year, more than one million people receive a diagnosis. Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years. Approximately 15% of colon cancer patients have dMMR or MSI-H tumors. These tumors exhibit higher mutation rates. Resulting in they may respond more effectively to immunotherapy treatments.
The National Cancer Institute sponsored the ATOMIC study. In addition, the Alliance for Clinical Trials in Oncology conducted the research. Genentech partnered on the study with the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. Together, the organizations worked to advance treatment options for difficult-to-treat cancers. The collaboration also reflects Genentech’s ongoing commitment to partnering with leading academic research groups.
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News Source: Businesswire.com
