Xalkori Granted Second Indication
March 11, 2016 – The U.S. Food and Drug Administration granted approval for a new indication for Pfizer’s Xalkori (crizotinib); a Kinase inhibitor, which was originally approved in 2011 for the treatment of metastatic non-small cell lung cancer (NSCLC) that has been detected by an FDA-approved genetic test to be anaplastic lymphoma kinase (ALK)-positive. The new indication now allows the drug to be used to treat patients with ROS1-positive metastatic NSCLC. The drug had been given Breakthrough Therapy and Priority Review designations for treating ROS1-positive NSCLC tumors in 2015, while awaiting results of the clinical trial. One out of the 50 patients in the Phase 1 study had a complete response to 250mg of the drug given twice daily, while 32 of them responded partially to treatment of the same dose and frequency. The American Cancer Society states that about 1% of newly diagnosed NSCLC patients in the world have ROS1 genetic mutations. A companion diagnostic test for ROS1 is currently in the pipeline.
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