ALK and non-small cell lung carcinoma: Crizotinib, the first-in-class tyrosine kinase inhibitor, was initially approved for use in ALK-positive NSCLC patients in the US in 2011 and in Canada in 2012 based on initial results from single-arm phase I and II trials (PROFILE 1001, PROFILE 1005), which reported median progression-free survival of 8–10 months among participants with previous treatment experience.