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FDA Approved PD-L1 (SP142) Assay for Lung Cancer

doi: 10.1097/01.COT.0000511177.08533.08
FDA Updates
FDA; lung cancer

FDA; lung cancer

The FDA has approved the PD-L1 (SP142) assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer who may benefit from treatment with atezolizumab.

PD-L1 (SP142) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma and NSCLC tissue. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.

This biomarker assay is the first to evaluate patient PD-L1 expression using both tumor cell and immune cell staining. Determining a patient's PD-L1 expression level can provide insight into the survival benefit that may be achieved from treatment with atezolizumab. This product is intended for in vitro diagnostic use.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
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