Pfizer, a global pharmaceutical giant headquartered in New York City, NY announced that the FDA has granted Breakthrough Therapy designation to its oncology drug XALKORI® (crizotinib) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).  XALKORI is a small-molecule tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK), ROS1, and another proto-oncogene receptor tyrosine kinase, MET. It currently is approved in the U.S. for the treatment of patients with ALK-positive metastatic NSCLC.  ALK status can be determined by an FDA-approved test.  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 showcase the importance of precision medicine.

 

Original Article:

http://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_u_s_fda_breakthrough_therapy_designation_for_xalkori_crizotinib_for_the_treatment_of_patients_with_ros1_positive_non_small_cell_lung_cancer