Roche's Tecentriq combination wins FDA approval for stage III colon cancer
The approval covers a subtype of the disease and marks the drug's twelfth use cleared in the United States.
Published
The FDA has approved Roche's Tecentriq in combination with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III colon cancer that is mismatch repair deficient, or dMMR, in adults and children aged two and older, Genentech said. The regimen is given after surgery to reduce the chance the cancer returns.
The approval rests on the Phase III ATOMIC study, published in The New England Journal of Medicine, which found the combination cut the risk of recurrence or death by 50% compared with chemotherapy alone, according to Genentech. Earlier reporting on the trial's priority review had cited a 36-month disease-free survival rate of 86% with Tecentriq plus the mFOLFOX6 regimen, against 76% for chemotherapy alone, according to StockTitan.
Genentech said nearly 25% of colon cancers are diagnosed at stage III, and that almost one in three patients at that stage see the disease return within five years. A separate estimate put the number of patients who could be treated under the new approval at roughly 22,500 a year, according to Tech Times. Genentech called the approval the first adjuvant immunotherapy regimen cleared for stage III dMMR colon cancer, and the twelfth indication for Tecentriq in the United States.
The clearance moves Tecentriq into earlier-stage disease, widening its label beyond the metastatic settings where rivals are still waiting, including Exelixis's zanzalintinib combination, which is not expected until 2027. It follows a run of oncology approvals across the industry, among them Eli Lilly's Inluriyo in breast cancer and a priority review for Bayer's Lynkuet, in a field that has grown increasingly crowded even as Roche adds a new use for its drug. Treating patients after surgery rather than once the disease has spread reaches a larger pool of patients, giving Tecentriq a commercial path separate from the later-stage competition that Exelixis and others are pursuing.