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Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab and pembrolizumab

Eckstein, Markus ; Erben, Philipp ; Kriegmair, Maximilian C. ; Worst, Thomas S. ; Weiß, Cleo-Aron ; Wirtz, Ralph M. ; Wach, Sven ; Stoehr, Robert ; Sikic, Danijel ; Geppert, Carol I. ; Weyerer, Veronika ; Bertz, Simone ; Breyer, Johannes ; Otto, Wolfgang ; Keck, Bastian ; Burger, Maximilian ; Taubert, Helge ; Weichert, Wilko ; Wullich, Bernd ; Bolenz, Christian ; Hartmann, Arndt ; Erlmeier, Franziska


Background: Recently, the Food and Drug Administration (FDA)/European Medicines Agency (EMA) restricted first-line use of atezolizumab and pembrolizumab in patients with metastasised urothelial carcinoma by defining distinct programmed cell death ligand-1 cut-offs. We analysed the diagnostic performance of all FDA/EMA-approved programmed cell death ligand-1 assays with emphasis on new ...


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