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EDITORIAL Benjamin Solomon, MBBS, PhD, FRACP rizotinib (Xalkori) is an orally available, small molecule inhibitor of the ALK, ROS1 Cand c-MET tyrosine kinases. It is standard of care for the management of ALK-positive 1,2 3 non-small cell lung cancer (NSCLC) and has activity in ROS1 rearranged NSCLC and c-MET amplified NSCLC. Accelerated approval of crizotinib by the U.S. Food and Drug Administration was granted in August 2011 for the treatment of advanced ALK-positive NSCLC on basis of a phase I and phase II trial, with initial data from 255 patients. Since then, crizotinib has been approved in approximately 78 countries and received by thousands of ALK-positive NSCLC patients worldwide. Data from the initial clinical trials with crizotinib indicated that it was effective, safe, XXX and generally well tolerated. In the phases 1, 2, and 3 studies of crizotinib, the most often reported adverse events were visual changes, nausea, diarrhea, vomiting, edema, constipa- 1,2,5,6 tion, and elevated transaminases. The most serious toxicities were hepatotoxicity and 1,2,5,6 pneumonitis. As one would expect, with increasing clinical experience with crizotinib over recent years other toxicities have been described including asymptomatic bradycar- 7 6 dia and decreased total testosterone in males. In this issue
Journal of Thoracic Oncology – Wolters Kluwer Health
Published: Nov 1, 2014
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