FDA approves crizotinib (Xalkori) for certain NSCLC patients

March 11, 2016

In 2011, the drug Crizotinib was initially approved for Non-Small Cell Lung Cancer (NSCLC) patients with genetic alterations of ALK in their tumors. In a separate study of NSCLC patients with genetic alterations of the ROS1 gene, fifty patients were enrolled with advanced, ROS1-rearranged NSCLC.  The objective response rate as determined by independent radiology review was 66%, with a median duration of response of 18 months. Based on this important study, crizotinib was granted breakthrough therapy designation by the FDA last year, and was approved on March 11, 2016.