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Roche ALK Test Gains FDA Approval as CDx for Zykadia

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Roche's Ventana ALK (D5F3) CDx to identify best responders to Novartis' non-small cell lung cancer drug Zykadia (ceritinib).

The immunohistochemistry test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements, including patients whose cancer has spread to the brain. The assay is available for use on BenchMark IHC/ISH instruments, and is also indicated to identify best responders to Pfizer's ALK inhibitor, Xalkori (crizotinib).

"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," Ann Costello, head of Roche Tissue Diagnostics, said in a statement.