Global pharma giant Roche has secured a major regulatory step forward in its bid to expand use of its cancer immunotherapy.
This, after the US FDA accepted its supplemental Biologics License Application (sBLA) for adjuvant use of Tecentriq and Tecentriq Hybreza in combination with chemotherapy for stage III dMMR/MSI-H colon cancer.
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized by high mutation rates.
“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, 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.”
The urgency behind the filing is underscored by patient outcomes.
“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."
The application is backed by the ATOMIC study, published in The New England Journal of Medicine.
The trial showed that adding Tecentriq to standard FOLFOX6 chemotherapy cut the risk of disease recurrence or death by 50% versus chemotherapy alone in patients with stage III dMMR colon cancer. Three-year disease-free survival reached 86% in the Tecentriq combination arm, compared with 76% for chemotherapy alone.
Safety outcomes were consistent with prior studies of Tecentriq and FOLFOX6.
Colon cancer remains one of the world’s most common and deadly cancers, with more than one million diagnoses annually. Despite surgery and chemotherapy, around 30% of stage III patients relapse within five years.
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