U.S. Food and Drug Administration
FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
Published in Medical Letter on the CDC and FDA, September 18th, 2011
Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.
This ALK gene abnormality causes cancer development and growth. About 1 percent to 7 percent of those with...
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