Pfizer announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib). Xalkori is a treatment for metastatic non-small cell lung cancer (NSCLC) patients whose tumors are ROS1-positive.

The sNDA submission was based on data from a multicenter, single-arm Phase 1 study,  which evaluated Xalkori in 53 patients with ROS1-positive metastatic NSCLC. Data showed that Xalkori exhibited marked anti-tumor activity in these patients, with safety profile consistent with that observed in patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC. 

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The FDA granted Breakthrough Therapy designation to Xalkori for this potential indication in April 2015. If approved, Xalkori would become the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC.

Xalkori is a kinase inhibitor currently indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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