FDA approves Roche’s lung cancer companion diagnostic

The US Food and Drug Administration (FDA) have approved Roche’s 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.

"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.