Keytruda, Tecentriq Labeling Updated With PD-L1 Testing Requirements

Two different companion diagnostic tests were approved
Two different companion diagnostic tests were approved

The Food and Drug Administration (FDA) has updated the labeling for Keytruda (pembrolizumab; Merck) and Tecentriq (atezolizumab; Genentech) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue in patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. 

The Dako PD-L1 IHC 22C3 PharmDx Assay has been approved as a companion diagnostic to identify patients with with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The assay uses a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells to determine PD-L1 expression. The indication for Keytruda in the prescribing information has been updated to include the use of an FDA-approved test in the first-line setting for patients who are cisplatin-ineligible. 

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The Ventana PD-L1 (SP142) Assay has been approved as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Tecentriq. The assay determines PD-L1 expression in immune cells. The indication for Tecentriq in the prescribing information has been updated to include the use of an FDA-approved test in the first-line setting for patients who are cisplatin-ineligible. 

Second-line indications for treatment of urothelial carcinoma for both medications have remained the same. 

Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, is also indicated to treat various  colorectal, gynecologic, hematologic, skin, respiratory, and head and neck cancers. Tecentriq, a programmed death-ligand 1 (PD-L1) blocking antibody, is also indicated to treat non-small cell lung cancer (NSCLC)

For more information visit FDA.gov.