MONDAY, Aug. 29, 2011 (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 news release.
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.
Visit the U.S. Food and Drug Administration to learn more about this approval.