FDA grants priority review for Roche’s Tecentriq combo sBLA

The application covers patients with stage III colon cancer characterised by deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) or microsatellite instability-high (MSI-H).

The FDA is anticipated to make its decision on this regimen by 9 October 2026.

Roche’s submission is supported by data from the Phase III ATOMIC study, which was recently published in The New England Journal of Medicine.

The trial showed that Tecentriq combined with standard folinic acid, fluorouracil and oxaliplatin regimen (FOLFOX6) chemotherapy reduced the risk of recurrence or death by 50% compared with chemotherapy alone for people diagnosed with stage III dMMR colon cancer.

At 36 months, disease-free survival was 86% for Tecentriq and chemotherapy compared to 76% for chemotherapy only. The safety profile aligned with previous studies.

Roche is seeking additional regulatory approvals for the therapy, including from the European Medicines Agency (EMA), to expand access to this immunotherapy-based option for dMMR/MSI-H colon cancer.

The randomised, open-label, multi-centre ATOMIC study enrolled 712 patients.

Tecentriq is a monoclonal antibody that targets the PD-L1 protein on tumour and immune cells.

It has received approval for use in treating multiple difficult-to-treat cancers and is available in both subcutaneous and intravenous forms.

Roche global product development head and chief medical officer Levi Garraway said: “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.

“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.”

Earlier this month, the FDA accepted priority review of the new drug application for Roche’s investigational oral selective oestrogen receptor degrader, giredestrant, for breast cancer.

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