Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients.
Roche announced U.S. 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.
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.
(Source: PR Newswire)
Filed Under: Drug Discovery