On June 1, 2017, Roche (SIX: RO, ROG; OTCQX:RHHBY) announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for ZYKADIA.
Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients
- More than 1.6 million people die globally from lung cancer each year.1
- ALK – anaplastic lymphoma kinase – is an important biomarker found in non-small cell lung cancer (NSCLC). Its detection and inhibition can help shrink tumors in some ALK-positive patients.
- The VENTANA ALK (D5F3) CDx Assay2 identifies ALK-positive NSCLC patients eligible for treatment with the Novartis drug ZYKADIA® (ceritinib), expanding current treatment options.
Lung cancer remains the leading cause of cancer deaths, with more than 1.6 million deaths worldwide each year.1
“With the FDA’s approval of the expanded use of the VENTANA ALK (D5F3) CDx Assay to determine which lung cancer patients are eligible for ZYKADIA, we are helping clinicians and their patients identify additional treatment options for non-small cell lung cancer,” said Ann Costello, Head of Roche Tissue Diagnostics. “This is another example of Roche’s continued commitment to advancing the standard of care for lung cancer patients and personalized medicine.”
The VENTANA ALK (D5F3) CDx Assay is available for use on BenchMark IHC/ISH instruments.
About the VENTANA ALK (D5F3) CDx Assay
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib).
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
This product is intended for in vitro diagnostic (IVD) use. For more information, visit ALKIHC.com
For more information on ZYKADIA (ceritinib), visit www.hcp.novartis.com/products/zykadia/alk-nsclc/.
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 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.
VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.
1World Health Organization
2This product is intended for in vitro diagnostic (IVD) use.