The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza (subcutaneous atezolizumab and hyaluronidase-tqjs) as adjuvant treatment for patients with muscle-invasive bladder cancer who have circulating tumor DNA after cystectomy, as determined by Natera’s Signatera CDx. The approval marks the first FDA authorization of a ctDNA MRD-guided therapy in bladder cancer, alongside a simultaneous FDA authorization for Signatera as the companion diagnostic. Patients with a positive MRD result may receive adjuvant immunotherapy, while those with negative results may avoid treatment. FDA reviewed results from the Phase 3 IMvigor011 trial, in which 250 ctDNA-positive patients were randomized to Tecentriq or placebo. Disease-free survival was nearly doubled with Tecentriq (9.9 months vs 4.8 months), and median overall survival also improved (32.8 vs 21.1 months).