FDA Grants Xalkori Priority Review for Non-Small Cell Lung Cancer

FDA Grants Xalkori Priority Review for NSCLC
FDA Grants Xalkori Priority Review for NSCLC

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.

For more information call (800) 438-1985 or visit Pfizer.com.