Crizotinib Receives Breakthrough Therapy Designation for the Treatment of ROS1-Positive Non–Small Cell Lung Cancer
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 approved in the United States for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Breakthrough Therapy designation is intended to expedite the development and review of a potential new therapy if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.
The Breakthrough Therapy designation was based on a data analysis from an expansion cohort of a global phase I study (Study 1001), which evaluated crizotinib in 50 patients with ROS1-positive advanced NSCLC. These data, published last year in The New England Journal of Medicine, demonstrated that crizotinib exhibited marked antitumor activity in patients with ROS1-positive advanced NSCLC. The safety profile of crizotinib in ROS1-rearranged advanced NSCLC was similar to that observed in patients with ALK-positive advanced NSCLC.
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