The U.S. Food and Drug Administration has approved Tecentriq and Tecentriq Hybreza as adjuvant treatments for patients with muscle-invasive bladder cancer who test positive for circulating tumor DNA (ctDNA) after bladder removal surgery. The approval is tied to the Signatera CDx companion diagnostic, marking a major step toward precision oncology.
The decision was based on the Phase 3 IMvigor011 trial, where ctDNA-positive patients treated with atezolizumab achieved longer disease-free survival of 9.9 months compared with 4.8 months for placebo. Overall survival also improved to 32.8 months versus 21.1 months. The therapy additionally increased early ctDNA clearance rates.
Researchers said the approach could replace the traditional “watch and wait” strategy by identifying high-risk patients who may benefit from immediate immunotherapy while sparing ctDNA-negative patients from unnecessary treatment. Side effects were generally manageable and consistent with previous immunotherapy studies.