U.S. Food and Drug Administration
New U.S. Food and Drug Administration Findings from Massachusetts General Hospital Described
Published in Medical Letter on the CDC and FDA, January 29th, 2012
2012 JAN 29 -- "Crizotinib was recently approved by the US FDA for the treatment of advanced non-small cell lung cancer (NSCLC) harboring the ALK (anaplastic lymphoma kinase) gene rearrangement. To ensure identification of patients most likely to benefit, the FDA approved crizotinib concurrently with a companion diagnostic test-the Vysis ALK Break Apart FISH Probe Kit," scientists in Boston, Massachusetts report.
"This kit was used in 1 of the 2 pivotal trials leading to the FDA approval of crizotinib and has become the gold standard for detecting ALK rearrangement in NSCLC. Although ALK FISH is clinically validated, the assay can be technically challenging...
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