FDA Approves Genentech's Tecentriq for Muscle-Invasive Bladder Cancer with ctDNA-Guided Treatment
The U.S. Food and Drug Administration (FDA) has approved Genentech's Tecentriq (atezolizumab) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy. This approval marks the first ctDNA MRD-guided therapy, allowing healthcare professionals to tailor treatment to improve clinical benefits and reduce unnecessary interventions. The decision was based on the Phase III IMvigor011 study, which demonstrated that Tecentriq reduced the risk of disease recurrence or death by 36% and the risk of death by 41% in patients with detectable ctDNA MRD. The study utilized Natera's Signatera CDx personalized MRD assay to identify molecular evidence of cancer in the blood, enabling selective deployment of adjuvant immunotherapy. 
