FDA has granted Orphan Drug Designation to XALKORI (crizotinib) for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). XALKORI is a small-molecule tyrosine kinase inhibitor of ALK, ROS1, and another proto-oncogene receptor tyrosine kinase, MET. It is manufactured by Pfizer, a global pharmaceutical giant and is currently approved in the US for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive. This designation follows the Breakthrough Therapy Designation in April this year for the same indication. ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC and clinical studies have shown that XALKORI exhibited antitumor activities in this group of patients. NSCLC is a heterogeneous disease and the coupling of XALKORI treatment with companion diagnostic tests further approved the importance of precision medicine.