The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to crizotinib (Xalkori) for the potential treatment of patients with ROS1-positive non–small cell lung cancer (NSCLC). Crizotinib currently is FDA-approved for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive.
The Breakthrough Therapy designation was based on data from an expansion cohort of a global phase I study that evaluated crizotinib in 50 patients with ROS1-positive advanced NSCLC. These data, published last year in The New England Journal of Medicine,1 demonstrated that crizotinib exhibited marked antitumor activity in patients with ROS1-positive advanced NSCLC. ■
1. Shaw AT, Ou S-HI, Bang Y-J, et al: Crizotinib in ROS1-rearranged non-small cell lung cancer. N Engl J Med 371:1963-1971, 2015.