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FDA Approves Xalkori for Rare Genetic Form of Lung Cancer

Drug approval expanded to include patients with ROS1-positive NSCLC

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FRIDAY, March 11, 2016 (HealthDay News) -- Xalkori (crizotinib) has been approved by the U.S. Food and Drug Administration to treat advanced non-small-cell lung cancer (NSCLC) with tumors that have a rare ROS1 gene mutation.

The drug was approved in 2011 to treat advanced NSCLC that was related to an abnormal ALK gene, the agency said Friday in a news release.

Clinical studies of 50 people with ROS1-positive NSCLC found that about two-thirds (66 percent) of participants treated with Xalkori had complete or partial shrinkage of tumors that lasted for a median of 18.3 months, the agency said.

The drug's most common side effects include nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, loss of appetite, and upper respiratory infection. More serious adverse reactions could include liver problems, lung inflammation, abnormal heartbeat, and loss of vision.

Xalkori is marketed by New York City-based Pfizer.

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