KEYTRUDA® (Pembrolizumab) and TECENTRIQ® (Atezolizumab)

The FDA on August 16, 2018 updated the prescribing information for these two agents, to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are Cisplatin-ineligible. FDA approved two different companion diagnostic tests, the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic for treatment with KEYTRUDA® and Ventana PD-L1 (SP142) Assay® (Ventana Medical Systems, Inc.) as a companion diagnostic test for treatment with TECENTRIQ®.