US FDA nod for Roche’s VENTANA ALK (D5F3) CDx assay as companion diagnostic for NSCLC treatment with LORBRENA

Roche announced US 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 Pfizer’s drug LORBRENA (lorlatinib). The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

ALK-positive patients treated with ALK inhibitors in previous studies have shown progression-free survival of up to nearly three years. In contrast, progression-free survival for ALK-positive patients treated with chemotherapy in ALK inhibitor studies was seven to eight months.

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). The assay has been shown in studies to identify more NSCLC patients that may benefit from an anti-ALK target therapy than fluorescent in situ hybridisation (FISH) testing.6,7,8,9 The VENTANA ALK (D5F3) CDx Assay is available in the US for use on the BenchMark ULTRA and BenchMark XT immunohistochemistry/in situ hybridisation (IHC/ISH) slide staining instruments.