Roche announces FDA approval
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
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.
About TECENTRIQ
For more information on TECENTRIQ, visit the Genentech website at gene.com.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
