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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