Posted by Michael Wonder on 31 Aug 2016
Xalkori (crizotinib) receives approval in European Union for the treatment of patients with ROS1-positive advanced non-small cell lung cancer
31 August 2016 - Xalkori is the first and only approved biomarker-driven therapy for ROS1-positive advanced non-small-cell lung cancer in the EU.
Pfizer today announced that the European Commission has approved Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small-cell lung cancer (NSCLC). In the European Union (EU), Xalkori is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March of this year, Xalkori was approved by the U.S. FDA for patients with metastatic NSCLC whose tumors are ROS1-positive. With this approval, Xalkori becomes the only biomarker-driven therapy approved for patients with either ALK positive or ROS1-positive advanced NSCLC in the EU and U.S.
