Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 9, 2026
FDA adds Tecentriq to postsurgical treatment for stage III dMMR colon cancer
The agency also approved nine new molecular entities in September, bringing its year-to-date total to 45.
Today in brief
Roche’s Tecentriq, or its subcutaneous version Tecentriq Hybreza, can now be used with chemotherapy after surgery for certain patients with stage III dMMR colon cancer, following FDA approval.1 In the Phase III ATOMIC trial, Tecentriq plus modified FOLFOX6 cut the risk of recurrence or death by half compared with chemotherapy alone.1
CDER approved nine new molecular entities in September, taking its 2026 total to 45.2
Tecentriq gains a postsurgical role in stage III dMMR colon cancer
The FDA approved Roche’s Tecentriq, or the subcutaneous formulation Tecentriq Hybreza, with fluoropyrimidine and oxaliplatin for postsurgical treatment of certain patients with stage III mismatch repair-deficient (dMMR) colon cancer.1 The approval makes this the first immunotherapy-based option authorized for this patient group and treatment setting.1
The decision followed Phase III ATOMIC results, in which Tecentriq plus modified FOLFOX6 reduced the risk of recurrence or death by 50% compared with chemotherapy alone.1 Roche is pursuing additional European regulatory filings for Tecentriq in dMMR colon cancer.1