Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)
The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
- The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
- "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy.
- The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) and LORBRENA (lorlatinib).
- It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) or LORBRENA (lorlatinib) in the US.