FDA clears Roche's Tecentriq after surgery for stage III dMMR colon cancer

The US Food and Drug Administration approved Roche's PD-L1 antibody Tecentriq on 8 October 2026 for use alongside a fluoropyrimidine and oxaliplatin after surgery in stage III colon cancer with deficient DNA mismatch repair (dMMR) ². Roche announced the decision the following day and said it is the first adjuvant regimen built on immunotherapy to be approved for this group of patients ¹.

The label covers both the intravenous drug and the subcutaneous version, Tecentriq Hybreza ¹. The intravenous form is cleared for adults and for children aged two and over, while Tecentriq Hybreza is cleared for patients aged 12 and over who weigh at least 40 kg ². Roche counts this as the twelfth US indication for Tecentriq ¹.

What the trial found

The decision rests on ATOMIC, a phase III, randomised, open-label, multicentre study that enrolled 712 patients, 711 of them adults and one a child, after complete removal of the primary tumour ¹². Half received modified FOLFOX6 chemotherapy plus atezolizumab for 12 cycles and then atezolizumab alone for a further six months; the other half received 12 cycles of chemotherapy alone ². The primary measure was disease-free survival as judged by the investigator ².

The hazard ratio for disease-free survival was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), and neither arm had reached its median ². At 36 months, 86% of patients on the combination were alive and free of disease against 76% on chemotherapy alone, according to Roche, which said the safety profile matched earlier experience with both treatments ¹. The results have been published in The New England Journal of Medicine ¹.

Frank Sinicrope of the Mayo Clinic, who led the trial, said that "Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status" ¹. The study was sponsored by the US National Cancer Institute and run by the Alliance for Clinical Trials in Oncology, with Genentech supporting it under a cooperative research agreement and German sites joining through the AIO study group ¹.

What it means for the market

The approval splits post-surgical treatment of stage III colon cancer by mismatch repair status for the first time in the US label, which makes routine immunohistochemistry testing of resected tumours a condition of access. Roche names its own VENTANA MMR RxDx Panel as an example of such a test, so the decision supports its diagnostics business as well as the drug ¹. The addressable group is a minority: roughly 15% of colon cancer patients have dMMR or MSI-H tumours, nearly 25% of colon cancers are found at stage III, and nearly 30% of stage III patients relapse within five years despite surgery and chemotherapy ¹.

For European payers and regulators the decision is a signal rather than a change. Roche says it is pursuing further filings, including with the European Medicines Agency ¹. The FDA ran its review under Project Orbis with regulators in Australia, Canada, Israel and Switzerland, whose reviews are still in progress, and granted priority review ². Neither source mentions a UK filing or any pricing.

The treatment also lengthens time on drug. Patients receive atezolizumab for six months with chemotherapy and then for up to six more months on its own ², which adds up to a year of PD-L1 therapy per patient in an adjuvant setting.

The trial was open-label, and median disease-free survival had not been reached in either arm, so how long the benefit lasts is not yet known ². Dosing for children under 12, and for patients aged 12 and over who weigh less than 40 kg, has not been established for the subcutaneous form ². The label carries warnings on immune-mediated adverse reactions, infusion reactions, complications of allogeneic stem-cell transplantation and harm to a fetus ². Decisions from the EMA and the four Orbis partners are the next steps Roche and the FDA point to ¹².