FDA Approves Ventana ALK Assay as Companion Diagnostic for Pfizer's XALKORI

Strategic Insights -

The US FDA has approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to aid in the identification of patients for Pfizer's targeted therapy, XALKORI (crizotinib). This approval makes ALK IHC testing widely accessible on VENTANA BenchMark(1) immunohistochemistry instruments globally, and the assay provides fast test results with a binary, straightforward scoring method.

Key Takeaways:

  • The Ventana ALK (D5F3) CDx Assay is a companion diagnostic test approved by the FDA to aid in the identification of patients for Pfizer's XALKORI (crizotinib).
  • The test provides physicians and patients a fast and accurate method to identify ALK protein expression.
  • Ventana used the VENTANA ALK (D5F3) CDx assay and scoring method to retrospectively test patient samples from Pfizer-sponsored clinical trials and demonstrated that the test is effective in identifying patients with ALK-positive NSCLC.
  • The success of the VENTANA ALK (D5F3) CDx Assay is an example of Roche's commitment to advancing the standard of care for patients.
  • The approval of the Ventana ALK (D5F3) CDx Assay is significant because it makes ALK IHC testing widely accessible and provides fast test results.
  • Lung cancer is the leading cause of cancer-related death worldwide, with NSCLC being the most common sub-type.
  • The detection of ALK positivity is important for NSCLC patients because inhibition of the ALK tyrosine kinase has led to tumor shrinkage for ALK-positive patients.
  • XALKORI (crizotinib) is an oral first-in-class ALK inhibitor that has been shown to block important growth and survival pathways which may shrink or slow the growth of tumors.
  • Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients.

Statistics:

  • Lung cancer is the leading cause of cancer-related death worldwide and in the United States.
  • NSCLC is the most common sub-type of lung cancer.
  • The detection of ALK positivity is very important for NSCLC patients because inhibition of the ALK tyrosine kinase has led to tumor shrinkage for ALK-positive patients.
  • XALKORI (crizotinib) is an oral first-in-class ALK inhibitor.
  • Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker.

Sources:

  • Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, announced approval of the VENTANA ALK (D5F3) CDx Assay by the US Food and Drug Administration (FDA).
  • Pfizer's XALKORI (crizotinib) Prescribing Information.
  • Ventana Medical Systems, Inc. ("VMSI") (SIX: RO, ROG; OTCQX:RHHBY), a member of the Roche Group.