MONDAY, Aug. 29 (HealthDay News) -- Xalkori (crizotinib) and a
companion diagnostic test have been approved by the U.S. Food and
Drug Administration to treat advanced non-small cell lung cancer
(NSCLC) with a certain genetic abnormality, the agency said in a
The test and drug are aimed at NSCLC cancers that express an
abnormal anaplastic lymphoma kinase (ALK) gene, which triggers
cancer development and growth. About 1 percent to 7 percent of
NSCLC cancers have the gene abnormality, the FDA said. Most people
with this form of lung cancer are nonsmokers.
The drug's safety and effectiveness were established in a pair
of clinical studies involving a total of 255 patients with
late-stage ALK-positive NSCLC. Accelerated approval was granted
under a program that allows the agency to approve a medication if
it is "reasonably likely to predict a clinical benefit to
patients," the FDA said.
The most common side effects of Xalkori included vision
problems, nausea, diarrhea, vomiting, swelling and constipation.
The drug also has been associated with potentially life-threatening
inflammation of lung tissue (pneumonitis).
Xalkori is marketed by Pfizer, based in New York City.
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