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The Food and Drug Administration has granted Breakthrough Therapy status to Xalkori (crizotinib) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).

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Xalkori, a kinase inhibitor made by Pfizer Oncology, is currently approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test (OT 12/25/13 issue).


The Breakthrough Therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.


Xalkori's application is based on a data analysis from an expansion cohort of a global Phase I study that evaluated the drug in 50 patients with ROS1-positive advanced NSCLC. The data showed marked antitumor activity for the patients in the cohort-with three complete responses and 33 partial responses. Median duration of response for the patients was 17.6 months. The safety profile of XALKORI in ROS1-rearranged advanced NSCLC was similar to that observed in patients with ALK-positive advanced NSCLC.