Posted by Michael Wonder on 09 Mar 2021
Roche receives FDA approval for Ventana ALK (D5F3) CDx assay to identify lung cancer patients eligible for targeted treatment with Lorbrena (lorlatinib)
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments, providing more options to lung cancer patients.
Roche today announced US FDA approval of the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK positive non-small cell lung cancer patients eligible for treatment with Pfizer's Lorbrena (lorlatinib).
The Ventana ALK (D5F3) CDx Assay is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Lorbrena.
