SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) said Friday that the U.S. FDA approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), in combination with chemotherapy, for the adjuvant treatment of Stage 3 mismatch repair-deficient (dMMR) colon cancer.
The treatments are approved for use with fluoropyrimidine- and oxaliplatin-based chemotherapy, including the modified FOLFOX6 (mFOLFOX6) regimen. The approval marks Tecentriq's 12th indication in the U.S. added the company.
Colon cancer is a malignancy affecting the large intestine. The dMMR subtype involves defects in the DNA mismatch repair system, resulting in a higher mutation rate. According to Roche, more than one million people are diagnosed with colon cancer globally each year, and nearly 25% of all cases are diagnosed at stage 3.
Tecentriq is a PD-L1-blocking monoclonal antibody designed to help reactivate T cells against cancer cells. The approval provides an adjuvant immunotherapy option for this patient population following surgery.
The approval was supported by the Phase 3 ATOMIC trial, which enrolled 712 patients with stage 3 dMMR colon cancer. The primary endpoint for the study was disease-free survival (DFS).
Patients received mFOLFOX6, a chemotherapy combination of folinic acid, fluorouracil and oxaliplatin, with or without Tecentriq.
The study showed that adding Tecentriq to mFOLFOX6 reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone.
Three-year DFS was 86% with Tecentriq plus chemotherapy, versus 76% with chemotherapy alone.
The safety profile was consistent with those previously reported for Tecentriq and mFOLFOX6, Roche said.
Roche said it is pursuing additional regulatory filings for Tecentriq, including with the European Medicines Agency, to expand access to the adjuvant treatment for patients with dMMR colon cancer worldwide.
RHHBY closed on Thursday at $53.37, down 1.29% on the OTC Markets.
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