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 ROS-1 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.
Lung cancer is the leading cause of cancer death in the United States. Last year, more than 221,000 cases were diagnosed and more than 158,000 people died from it, the FDA said.
Clinical studies of 50 people with ROS-1-positive NSCLC found that about two-thirds of participants treated with Xalkori had their tumors partially or completely shrink for an average of 18 months, the agency said.
The drug’s most common side effects include nausea, diarrhea, vomiting, swelling, constipation, elevated liver enzymes, 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.
Learn more about this approval from the FDA.