Crizotinib (Xalkori)

==General information==
Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK), c-MET and subsequent expression of Hepatocyte Growth Factor Receptor (HGFR), and Recepteur d’Origine Nantais (RON). Inhibits activity of fusion proteins involving ALK, such as EML4-ALK and NPM-ALK.Crizotinib (Xalkori) package insert Crizotinib (Xalkori) package insert (locally hosted backup)
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is used==
*Anaplastic large cell lymphoma, pediatric
*ALK+ non-small cell lung cancer
*ROS1+ non-small cell lung cancer
==Patient drug information==
*Crizotinib (Xalkori) package insert pages 15-18
*Crizotinib (Xalkori) patient drug information (Chemocare)Crizotinib (Xalkori) patient drug information (Chemocare)
*Crizotinib (Xalkori) patient drug information (UpToDate)Crizotinib (Xalkori) patient drug information (UpToDate)
==History of changes in FDA indication==
===Anaplastic large cell lymphoma, pediatric===
*2021-01-14: Approved for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. (New disease entity; based on COG ADVL0912)
===Inflammatory myofibroblastic tumor===
*2022-07-14: Approved for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). (New disease entity; based on COG ADVL0912 & PROFILE 1013)
===Non-small cell lung cancer===
*2011-08-26: Initial accelerated approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. (Based on PROFILE 1001 ALK)
**2013-11-20: Converted to full approval for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. (Indication removed from locally advanced setting; based on PROFILE 1005, PROFILE 1007, PROFILE 1014)
*2016-03-11: Approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. (New mutation-specific indication; based on PROFILE 1001 ROS1)
==History of changes in EMA indication==
*2012-10-23: Initial marketing authorization as Xalkori.
*Uncertain date: Indicated for first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC).
*Uncertain date: Indicated for treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC).
*Uncertain date: Indicated for treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC).
*Uncertain date: Indicated for treatment of paediatric patients (age 1 up to 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL).
*Uncertain date: Indicated for treatment of paediatric patients (age 1 up to 18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT).
==History of changes in Health Canada indication==
*2012-04-25: Initial notice of compliance with conditions as monotherapy for use in patients with ALK-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). 
**2015-11-18: Conditions were met
*2017-08-28: New indication for patients with ROS-1 positive advanced non-small cell lung cancer (NSCLC).
==History of changes in PMDA indication==
*2012-03-30: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive non-small cell lung cancer.
*2017-05-18: New additional indication for the treatment of unresectable advanced/relapsed ROS1 fusion gene-positive non-small cell lung cancer.
==Also known as==
*Code names: PF-02341066
*Brand name: Alkixen, Crizalk, Crizocap, Crizocent, Crizonix, Kayzoni, Lucicriz, Rizonib, Xalkori
==References==
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:ALK inhibitors
Category:MET inhibitors
Category:ROS1 inhibitors
Category:Anaplastic large cell lymphoma, pediatric medications
Category:Inflammatory myofibroblastic tumor medications
Category:Non-small cell lung cancer medications
Category:EMA approved in 2012
Category:FDA approved in 2011
Category:Health Canada approved in 2012
Category:PMDA approved in 2012