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Treating Anaplastic Lymphoma Kinase-Positive Lung Cancer in the Weeks After the US Food and Drug Administration Approval of Crizotinib.

On August 26, 2011 the US Food and Drug Administration (FDA) approved the anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor crizotinib (Pfizer; New York, NY) for the treatment of patients with advanced non–small-cell lung cancer (NSCLC) with translocations of the ALK gene as determined by an FDA-approved companion genetic test.1 The approval was based on a high response rate in 255 patients with ALK-positive NSCLC treated with the drug as part of two early-phase trials.2–3 This is the first new FDA-approved drug for advanced NSCLC in the last 5 years, to our knowledge, and there is much enthusiasm about the approval among patients and practitioners. 
 
As an oncologist specializing in the treatment of patients with lung cancer, I had suspected that crizotinib would be approved sometime in 2011. However, I also worried that there would be growing pains in prescribing this new (and expensive) drug for a small, genetically defined subpopulation. When a new drug is approved, the pharmaceutical company usually does not yet have mass production up and running and starts out with a limited supply produced for research purposes. For crizotinib the drug was initially made available only through three specialty mail-order pharmacies. In addition, insurance companies need time to develop policies for coverage of crizotinib in a molecularly defined (ALK-positive) patient population. As it turns out, all of my concerns would come to life in the form of three young men in just the first couple of weeks after the approval.