Roche：Tecentriq®Atezolizumab was submitted for marketing approval in the U.S. and granted Priority Review designation.
On June 11 local time, Roche announced that the U.S. FDA has accepted the company’s supplemental Biologics License Application (sBLA) seeking approval for atezolizumab (Tecentriq®) and atezolizumab and hyaluronidase injection (Tecentriq Hybreza®) in combination with chemotherapy as adjuvant treatment for stage III mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer. The FDA has granted Priority Review to the application and is expected to make an approval decision by October 9, 2026.
This submission is based on the ATOMIC study (NCT02912559), a Phase III, randomized, open-label, multicenter study designed to investigate the addition of atezolizumab to FOLFOX6 chemotherapy (leucovorin, fluorouracil, and oxaliplatin) in patients with dMMR stage III colon cancer. A total of 712 patients were enrolled, with the primary endpoint being disease-free survival (DFS). The clinical data were recently published in The New England Journal of Medicine.
The ATOMIC study showed that for patients with stage III dMMR colorectal cancer identified by immunohistochemistry, adding atezolizumab to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% compared with FOLFOX6 alone. The 36-month disease-free survival rate was 86% in the atezolizumab plus FOLFOX6 arm versus 76% in the FOLFOX6-alone arm. The safety profile was consistent with previous studies of atezolizumab and FOLFOX6.
According to the press release, Roche is submitting further applications to regulatory authorities including the European Medicines Agency to provide the first immunotherapy-based adjuvant treatment option for patients with dMMR/MSI-H colorectal cancer worldwide.
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