Abstract
Crizotinib, an inhibitor of the receptor tyrosine kinase anaplastic lymphoma kinase (ALK), achieves response rates of 57 % at eight weeks in patients with stage IV non-small cell lung cancer with ALK rearrangements. With such results, the crizotinib followed an accelerated procedure in the United States and obtained the Food and Drug Administration (FDA) approval based on the results of phase I studies. The results should be confirmed with one phase II study and two phase III studies in patients with ALK rearrangements. In France, the Commission of Authorization for Marketing has granted an Authorization of Temporary Use (ATU) for cohort on the 15 December 2011 to allow its administration in patients before marketing authorization.
MeSH terms
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Anaplastic Lymphoma Kinase
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Carcinoma, Non-Small-Cell Lung / drug therapy*
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Carcinoma, Non-Small-Cell Lung / pathology
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Clinical Trials, Phase I as Topic
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Crizotinib
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Drug Approval
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France
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Gene Rearrangement / genetics
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Humans
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Lung Neoplasms / drug therapy*
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Lung Neoplasms / pathology
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Oncogene Proteins, Fusion / genetics
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Precision Medicine / methods
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Protein Kinase Inhibitors / adverse effects
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Protein Kinase Inhibitors / therapeutic use*
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Pyrazoles / adverse effects
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Pyrazoles / therapeutic use*
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Pyridines / adverse effects
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Pyridines / therapeutic use*
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Receptor Protein-Tyrosine Kinases / antagonists & inhibitors*
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Receptor Protein-Tyrosine Kinases / genetics
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Receptor Protein-Tyrosine Kinases / physiology
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United States
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United States Food and Drug Administration
Substances
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Antineoplastic Agents
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EML4-ALK fusion protein, human
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Oncogene Proteins, Fusion
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Protein Kinase Inhibitors
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Pyrazoles
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Pyridines
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Crizotinib
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ALK protein, human
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Anaplastic Lymphoma Kinase
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Receptor Protein-Tyrosine Kinases