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Xalkori approved for NSCLC treatment

The United States Food and Drug Administration (USFDA) has approved oral Xalkori (Crizotinib) for treatment of metastatic non-small cell lung cancer (NSCLC), particularly for patients with ROS-1 gene mutation. Xalkori is the first approved drug for ROS-1 positive NSCLC.


Xalkori inhibits ROS-1 protein expression in tumors, by which the drug attenuates tumor growth and metastases.


In phase-III studies, about 66% of subjects experience complete or partial shrinkage of metastatic tumors and the treatment benefit lasted a median period of 18.3 months.


Some of the common reported adverse events of Xalkori are raised hepatic function test biomarkers, anorexia, nausea or vomiting, GI disturbances, edema, dizziness, neuropathy, upper respiratory infection, numbness and tingling. Xalkori may cause serious adverse events including fatal lungs inflammation, abnormal cardiac rhythms, hepatotoxicity, partial or complete loss of vision in one or both eyes.

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