Roche announces FDA approval for VENTANA PD-L1 (SP142) Assay to support immunotherapy treatment decisions in lung cancer
First FDA-approved test to support patient treatment decisions for TECENTRIQ (atezolizumab) in non-small cell lung cancer
Tucson, AZ, October 27, 2016– Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay1 by the U.S. Food and Drug Administration (FDA) 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 (NSCLC).2 The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC) who may benefit from treatment with TECENTRIQ.
This innovative 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 TECENTRIQ.
Lung cancer remains the leading cause of cancer deaths with an annual estimated 12.9 percent of all new cancer cases and nearly 1.59 million deaths worldwide – about one in five cancer-related deaths. NSCLC, one of two major types of lung cancer, accounts for approximately 85 percent of all lung cancer cases.3 During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.4
The VENTANA PD-L1 (SP142) Assay can now be performed on the VENTANA BenchMark ULTRA automated tissue staining instrument. With an established presence in laboratories globally, availability of the assay on the VENTANA BenchMark ULTRA instrument can provide broader access for patients and decrease the time spent waiting for PD-L1 test results.
“The approval of the VENTANA PD-L1 (SP142) Assay with TECENTRIQ underscores Roche’s personalized healthcare strategy to provide innovative diagnostic tools that deliver valuable medical information which helps guide treatment decisions for physicians and their patients,” said Ann Costello, Head of Roche Tissue Diagnostics.
Roche will continue to pursue regulatory approval for the VENTANA PD-L1 (SP142) Assay in combination with TECENTRIQ in other cancer indications and in other geographies. For more information, go to PDL1ihc.com.
1This product is intended for in vitro diagnostic (IVD) use.
2PD-L1 testing is not required for the use of TECENTRIQ, but it may provide additional information for physicians and inform patient dialogue.
3Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. http://globocan.iarc.fr. Published 2013-12-12. Updated 2014-01-09. Accessed 2016-02-08.
4Siegel R, Naishadham D, Jemal A. Cancer Statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.
About the VENTANA PD-L1 (SP142) Assay
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 (FFPE) urothelial carcinoma and non-small cell lung cancer (NSCLC) 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 (% TC) of any intensity.
PD-L1 expression in ≥ 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).
PD-L1 expression in ≥ 50% TC or ≥ 10% IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ (atezolizumab). This product is intended for in vitro diagnostic (IVD) use.
For more information on TECENTRIQ, visit the Genentech website at gene.com.
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Positive NSCLC tissue stained with PD-L1 (SP142) assay, 10x
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