Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy

June 11, 2026: Roche (SIX: RO, ROP; OTCQX: RHHBY) announced the FDA has accepted its supplemental BLA for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) plus chemotherapy for stage III dMMR/MSI-H colon cancer after surgery. The application received Priority Review, with an FDA decision expected by October 9, 2026.

The filing is supported by the Phase III ATOMIC trial (A021502; NCT02912559), sponsored by the NCI and run by the Alliance for Clinical Trials in Oncology with partners including Roche. In ATOMIC (n=712), adding Tecentriq to FOLFOX6 reduced the risk of disease recurrence or death by 50% versus FOLFOX6 alone; 36-month disease-free survival was 86% with Tecentriq+FOLFOX6 vs 76% with FOLFOX6 alone. Safety was consistent with prior Tecentriq and FOLFOX6 experience.

Roche also stated it is pursuing additional regulatory filings, including with the European Medicines Agency.