The FDA approved atezolizumab (Tecentriq) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients with circulating tumor DNA (ctDNA) after cystectomy, using Natera’s Signatera CDx personalized molecular residual disease (MRD) assay to guide treatment. The decision marks the first FDA approval of a ctDNA MRD-guided therapy in bladder cancer and the first time a blood-based MRD assay received CDx authorization.
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