Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), said on Thursday that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application for Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for patients with stage III dMMR/MSI-H colon cancer following surgery.

The FDA has granted Priority Review and is expected to make an approval decision by 9 October 2026.

The filing is supported by results from the Phase III ATOMIC study, which showed that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone. The study also reported 36-month disease-free survival of 86% for the Tecentriq combination versus 76% for FOLFOX6 alone. The safety profile observed in the ATOMIC study was consistent with previous studies of Tecentriq and FOLFOX6.

Genentech noted that approximately 30% of stage III colon cancer patients relapse within five years despite surgery and chemotherapy, while around 15% of patients have dMMR/MSI-H tumors.

The ATOMIC trial was sponsored by the National Cancer Institute and conducted by the Alliance for Clinical Trials in Oncology in partnership with Genentech and Germany's Arbeitsgemeinschaft Internistische Onkologie (AIO) group.