The European Commission has approved Pfizer’s Xalkori (crizotinib, a kinase inhibitor, for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).

Xalkori was previously approved in the European Union for treating adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March 2016, Xalkori was approved by the US Food and Drug Administration for patients with metastatic NSCLC whose tumors are ROS1-positive. It was first approved in the US in 2011 to treat (ALK)-positive advanced NSCLC. In 2015, it posted global sales of $488 million. 

ROS1 rearrangements occur when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. Epidemiology data suggest that ROS1 rearrangements occur in approximately 1% of NSCLC cases, according to information from Pfizer.

Source: Pfizer