Xalkori Granted Breakthrough Therapy Designation By FDA
Pfizer announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Xalkori (crizotinib) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).
The Breakthrough Therapy designation for Xalkori was based on a data analysis from an expansion cohort of a global Phase 1 study (Study 1001), which evaluated Xalkori in 50 patients with ROS1-positive advanced NSCLC. The data showed that Xalkori exhibited marked anti-tumor activity in patients with ROS1-positive advanced NSCLC.
Xalkori, a kinase inhibitor is already indicated for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
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