The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients with circulating tumor DNA after cystectomy, using Natera’s Signatera CDx to guide treatment decisions. The decision represents the first FDA approval of a ctDNA MRD-guided therapy and the first authorization of a blood-based MRD assay as a CDx for this purpose. In IMvigor011, 250 patients who were ctDNA-positive by Signatera and had no radiographic evidence of disease were randomized to Tecentriq versus placebo. Disease-free survival was nearly doubled with Tecentriq (9.9 months vs. 4.8 months), and median overall survival was also longer (32.8 vs. 21.1 months).