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Crizotinib (Xalkori) Granted Regular FDA Approval for Treatment of Lung Cancer

Drug received accelerated approval in 2011 (November 21)

The FDA has granted crizotinib (Xalkori, Pfizer) regular approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test.

Crizotinib was previously granted accelerated approval in August 2011 because of the critical need for new agents for patients with ALK-positive NSCLC.

The FDA’s action was based on data from a pivotal phase III confirmatory trial that compared crizotinib with standard chemotherapy in previously treated patients. The results of this study were published in the June 20 issue of the New England Journal of Medicine.

Source: Pfizer; November 21, 2013.

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