Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer

Industry News

FDA has granted Orphan Drug Designation to XALKORI (crizotinib) for the treatment of ROS1-positive non-small cell lung cancer (NSCLC).  XALKORI is a small-molecule tyrosine kinase inhibitor of ALK, ROS1, and another proto-oncogene receptor tyrosine kinase, MET.  It is manufactured by Pfizer, a global pharmaceutical giant and is currently approved in the US for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive.  This designation follows the Breakthrough Therapy Designation in April this year for the same indication.  ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC and clinical studies have shown that XALKORI exhibited antitumor activities in this group of patients.  NSCLC is a heterogeneous disease and the coupling of XALKORI treatment with companion diagnostic tests further approved the importance of precision medicine.




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