Not yet, and no UK date has been set. The US FDA approved atezolizumab (Tecentriq) on 8 October 2026 for stage III dMMR colon cancer. NICE has an appraisal in scoping, with no publication date. The emc product summary for Tecentriq 1,200 mg lists six indications. Colon cancer is not among them.
This article answers one question: when could UK patients with dMMR colon cancer get atezolizumab? It sets out what the FDA approved, what the evidence shows, and which UK steps remain. Mismatch repair deficiency (dMMR) means the tumour cannot fix errors made when DNA is copied.
What the FDA approved for stage III dMMR colon cancer
The FDA approved atezolizumab with a fluoropyrimidine and oxaliplatin on 8 October 2026. The indication is adjuvant treatment, meaning treatment after surgery. It covers stage III dMMR colon cancer in adults and in children aged two years and older.
The FDA also approved a subcutaneous form, Tecentriq Hybreza. It is for patients aged 12 years and older who weigh at least 40 kg. The agency said both applications were granted priority review.
Roche said in June that the FDA was expected to decide by 9 October 2026. The approval came one day earlier. LSDN’s FDA drug approval decisions tracker listed the same 9 October target date.
Genentech, a member of the Roche Group, said this is the twelfth US indication for Tecentriq. In its release, Levi Garraway, Roche’s chief medical officer, called the approval a new option. He described it as “a new adjuvant treatment option for people with stage III dMMR colon cancer”.
What the ATOMIC trial showed in dMMR colon cancer
The FDA based its decision on ATOMIC, also coded ML39057 (NCT02912559). It was a randomised, open-label, active-controlled trial. It enrolled 711 adults and one paediatric patient with stage III dMMR colon cancer.
The New England Journal of Medicine paper reports 355 patients on atezolizumab plus mFOLFOX6 and 357 on mFOLFOX6 alone. The atezolizumab arm received both for 12 cycles, then atezolizumab alone for six months. The control arm received mFOLFOX6 for 12 cycles.
Disease-free survival
The major efficacy outcome was disease-free survival, assessed by the investigator. The FDA reports a hazard ratio of 0.50 (95% confidence interval 0.35 to 0.73; p=0.0001). Median disease-free survival was not reached in either arm.
At a median follow-up of 40.9 months, three-year disease-free survival was 86.3 per cent with atezolizumab. It was 76.2 per cent without it. Roche describes this as a 50 per cent cut in the risk of recurrence or death.
Frank Sinicrope is a professor of oncology at the Mayo Clinic. He is the US principal investigator. Until now, he said, the adjuvant standard of care “has not differed based on mismatch repair status”.
Safety and survival data
The paper reports grade 3 or 4 adverse events in 84.1 per cent of the atezolizumab arm. The control arm rate was 71.9 per cent. The atezolizumab arm rate was 12.2 percentage points higher.
OncLive, citing the NEJM paper, reported further safety figures. Grade 5 events occurred in six atezolizumab patients and two control patients. Two deaths in the atezolizumab arm, from sudden death and sepsis, were judged treatment related. LSDN could not access the full paper to confirm them.
OncLive also reported colitis in 6.6 per cent of the atezolizumab arm against 0.6 per cent. Hypothyroidism was 19.9 per cent against 3.9 per cent. The paper reports overall survival, a secondary endpoint, as similar between the arms.
The five-year survival rates were 89.7 and 87.9 per cent. The stratified hazard ratio was 0.90 (95% confidence interval 0.55 to 1.47). Median follow-up for that analysis was 45.8 months.
The paper also reports an exploratory analysis by chemotherapy cycles received. The hazard ratio was 0.41 (95% confidence interval 0.27 to 0.64) for more than six cycles. It was 0.97 for six or fewer, with a wide interval of 0.44 to 2.11. An exploratory result cannot support a dosing recommendation.
Will the NHS offer atezolizumab for dMMR colon cancer?
NICE has listed the topic as ID6646. Its title is atezolizumab with chemotherapy for adjuvant treatment of stage 3 colorectal cancer. The population has high microsatellite instability or mismatch repair deficiency. It is a standard single technology appraisal.
The NICE project page records that scoping began on 18 May 2026. Consultation on the draft scope ran from 18 May to 16 June 2026. The page does not give an expected publication date.
NICE’s remit is to appraise atezolizumab “within its marketing authorisation”. The draft scope was issued in May 2026. It states that the technology “does not currently have a marketing authorisation” for this use. That wording predates the FDA decision.
The draft scope lists three comparators. They are capecitabine plus oxaliplatin (CAPOX), FOLFOX, and capecitabine alone. ATOMIC tested only mFOLFOX6.
On 10 October 2026 LSDN read the emc entry for Tecentriq 1,200 mg. The indications are urothelial carcinoma, early and advanced non-small cell lung cancer, and small cell lung cancer. They also include triple-negative breast cancer and hepatocellular carcinoma. The page shows a last emc update of 31 July 2026.
LSDN did not locate any MHRA or European Medicines Agency decision on this indication. That is a dated search finding, not proof that no application exists. Roche said in June it “is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency”. The FDA page says the review ran under Project Orbis. It names regulators in Australia, Canada, Israel and Switzerland as collaborators. It does not name the MHRA.
How UK practice differs from the ATOMIC design
NHS pathways already test for mismatch repair status in colorectal cancer. NICE quality statement 1 says adults with a new diagnosis of colorectal cancer should have testing for Lynch syndrome. The same page notes that mismatch repair protein testing by immunohistochemistry can guide further tests.
Genentech says US eligibility is determined by “an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel”. Whether existing NHS testing would serve as the eligibility test is a question for NICE and NHS England.
The FDA indication names a fluoropyrimidine and oxaliplatin, which is wider than the mFOLFOX6 regimen tested. The sources LSDN read do not say whether the benefit carries over to CAPOX. NICE will need to address that gap.
ATOMIC was sponsored by the US National Cancer Institute and run by the Alliance for Clinical Trials in Oncology. Roche’s release adds that the German AIO group took part. None of the sources LSDN read names a UK site.
What would settle the UK question, and when
Three events would settle it. The first is a UK marketing authorisation covering this indication. No date for that is public. The second is a NICE timetable, which the project page gives as not yet stated.
The third is a NICE recommendation, which can only follow a licence. Until then, the answer to the opening question stays open. Adjuvant immunotherapy is moving quickly in other tumour types too. LSDN’s analysis of an adjuvant melanoma Phase 3 trial is one example.
Gaps in the evidence
The label covers children aged two years and older, yet ATOMIC enrolled one paediatric patient. The paediatric evidence is therefore minimal. Hybreza is restricted to patients aged 12 years and older.
The Genentech release carries no pricing or availability section, so LSDN has no price to report. Overall survival remains a secondary endpoint, with no difference shown between the arms so far.
Disease-free survival was investigator assessed and the trial was open label. Those design features are standard for this setting. They still mean the headline result rests on unblinded assessment.
