Strategies in ALK Rearranged NSCLC Patients

ALK-fusion positive (ALK+) NSCLC is estimated to account for 2–5 % of all lung cancer cases which translates to an incidence of more than 60,000 patients with this molecular subtype annually worldwide. The first step to treatment is accurate identification of the ALK fusion gene in the diagnostic biopsy. The gold standard objective method for detection of a gene fusion is fluorescent in situ hybridisation (FISH) and this is the currently approved detection method for ALK + NSCLC by the United States Food and Drug Administration (FDA). The first in class ALK inhibitor, crizotinib, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of ALK + NSCLC in August 2011 and by the European Medicines Evaluation Agency (EMEA) in July 2012. In this chapter the evidence base for crizotinib is summarized and ongoing strategies to overcome resistance to crizotinib, including other ALK inhibitors in development are discussed.