The Food and Drug Administration (FDA) granted approval to the drug alectinib (ALECENSA, Hoffman-La Roche, Inc/Genentech, Inc.) for the treatment of non-small cell lung cancer (NSCLC) patients with mutations/rearrangements in the “anaplastic lymphoma kinase (ALK) gene. The genetic alteration in ALK must be detected using an FDA-approved test. In 2015, alectinib had received accelerated approval for treatment of ALK-positive metastatic NSCLC patients whose disease had progressed on or who were intolerant of the drug crizotinib. Accelerated approval was granted based on an independent review committee (IRC)-assessed overall response rate of 38% and 44% among 87 and 138 patients, respectively in two clinical studies. The current approval is based on data from a clinical trial called “ALEX” (NCT02075840), which was a randomized, multi-center trial conducted on 303 patients with ALK-positive NSCLC who had not received prior therapy for metastatic disease.