Molecular Pathology Laboratory Network

The Food and Drug Administration (FDA) has approved Xalkori® (crizotinib) for late stage advanced or metastatic non-small-cell lung cancer (NSCLC) with Vysis ALK Break Apart FISH Probe Kit. The FDA's accelerated approval program allows drug approval for serious diseases and provides earlier access to patients for new drugs shown to provide clinical benefit. This is the second companion diagnostic and targeted therapy approved by the FDA this year.

Approximately 3-5% of NSCLC patients have ALK gene rearrangement, which drives tumor growth and is not a favorable prognostic factor in advanced NSCLC. Trial data indicate that patients with ALK rearrangement are more likely to respond to treatment with crizotinib.

A retrospective analysis, published in Lancet Oncology, showed that ALK-positive NSCLC patients treated with crizotinib have an improved, two-year survival compared with that of crizotinib-naive controls.

To detect if an ALK rearrangement is present in a NSCLC patient, MPLN offers ALK 2p23 gene rearrangement testing. NCCN guidelines recommend the use of the FDA approved fluorescence in situ hybridization (FISH) test for determining ALK gene rearrangement status.

For more information about this test, contact a client service specialist at 800.932.2943.