FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

摘要

Lung cancer is the leading cause of cancer death in the U.S., with more people dying of lung cancer than of colon, breast, and prostate cancers combined [id="xref-ref-1-1" class="xref-bibr" href="#ref-1">1]. Estimated new lung cancer cases for 2014 total 224,210, resulting in 159,260 deaths [id="xref-ref-2-1" class="xref-bibr" href="#ref-2">2]. Non-small cell lung cancer (NSCLC) accounts for 85% of new lung cancer cases, with a 5-year survival rate of 1%–16% [id="xref-ref-3-1" class="xref-bibr" href="#ref-3">3, id="xref-ref-4-1" class="xref-bibr" href="#ref-4">4]. Cytotoxic platinum doublet-based chemotherapy has been the standard first-line treatment for patients with metastatic NSCLC, with median survival of 8–10 months [id="xref-ref-5-1" class="xref-bibr" href="#ref-5">5]. In the second-line treatment setting for advanced NSCLC, docetaxel, pemetrexed (nonsquamous NSCLC only), and erlotinib are regimens approved by the U.S. Food and Drug Administration (FDA); however, response rates are low, less than 10%, and effects on survival are modest [id="xref-ref-6-1" class="xref-bibr" href="#ref-6">6].