Roche Receives FDA approval for VENTANA ALK CDx Assay 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.

"This FDA approval is great news for ALK-positive patients," said Jill German, Head of Roche Pathology Customer Segment. "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy. This label expansion advances Roche's commitment to personalized healthcare by providing lung cancer patients with access to more treatment options and a better chance for progression-free survival compared to the standard of care."

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. The VENTANA ALK (D5F3) CDx Assay is available in the US for use on the BenchMark ULTRA and BenchMark XT immunohistochemistry/in situ hybridization (IHC/ISH) slide staining instruments.

VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer tissue stained with a BenchMark ULTRA or BenchMark XT automated staining instrument. 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.