publication date: Nov. 4, 2016

Drugs and Targets Roche Receives FDA Approval for Tecentriq Complementary Diagnostic in NSCLC

VENTANA PD-L1 assay received FDA approval as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer.

The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer who may benefit from treatment with Tecentriq. The assay is sponsored by Roche.

The biomarker assay is the first to evaluate patient PD-L1 expression using both tumor cell and immune cell staining, the company said. Determining a patient’s PD-L1 expression level can provide insight into the survival benefit that may be achieved from treatment with Tecentriq.

The company said it will continue to seek additional indications for this drug and diagnostic.

Ventana 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 non-small cell lung cancer tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a Ventana BenchMark ULTRA instrument. 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 (% … Continue reading Roche Receives FDA Approval for Tecentriq Complementary Diagnostic in NSCLC

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