TECENTRIQ (atezolizumab) and TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) plus chemotherapy
Adjuvant treatment of stage III dMMR/MSI-H colon cancer · Patients with resected stage III deficient DNA mismatch repair or microsatellite instability-high colon cancer
RHHBY · Roche Holdings AG
Regulatory designations
Full timeline
3 milestonesFDA decision expected
FDA assigned an October 9, 2026 PDUFA goal date to the supplemental BLA for TECENTRIQ and TECENTRIQ HYBREZA in combination with chemotherapy for adjuvant treatment of stage III dMMR/MSI-H colon cancer.
Roche — Tecentriq sBLA acceptance and PDUFA date↗FDA accepted the sBLA with Priority Review
FDA accepted the supplemental BLA and granted Priority Review based on the Phase 3 Alliance ATOMIC study.
Roche — Tecentriq sBLA acceptance and Priority Review↗Phase 3 ATOMIC data supported the filing
The Phase 3 ATOMIC study found that adding TECENTRIQ to FOLFOX6 chemotherapy reduced the risk of recurrence or death by 50% versus chemotherapy alone in stage III dMMR colon cancer.
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