Difference between revisions of "Crizotinib (Xalkori)"
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===[[Anaplastic large cell lymphoma, pediatric]]=== | ===[[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, pediatric|anaplastic large cell lymphoma (ALCL)]] that is [[Biomarkers#ALK|ALK]]-[[Biomarkers#Rearrangement|positive]]. ''(New disease entity; based on COG ADVL0912)'' |
===[[Inflammatory myofibroblastic tumor]]=== | ===[[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 [[Inflammatory myofibroblastic tumor|myofibroblastic tumors (IMT)]]. ''(New disease entity; based on COG ADVL0912 & PROFILE 1013)'' |
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
| − | * | + | *2011-08-26: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm Initial accelerated approval] for the treatment of patients with locally advanced or metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] that is [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]]. ''(Based on PROFILE 1001 ALK)'' |
| − | *11 | + | *2013-11-20: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm Approved] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]]. ''(Indication removed from locally advanced setting; based on PROFILE 1005, PROFILE 1007, PROFILE 1014)'' |
| − | * | + | *2016-03-11: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm490391.htm Approved] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ROS1|ROS1]]-[[Biomarkers#Rearrangement|positive]]. ''(New mutation-specific indication; based on PROFILE 1001 ROS1)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *10 | + | *2012-10-23: Initial marketing authorization as Xalkori. |
| + | ==History of changes in Health Canada indication== | ||
| + | *2012-04-25: Initial notice of compliance with conditions | ||
| + | *2015-11-18: Conditions were met | ||
==Also known as== | ==Also known as== | ||
| Line 52: | Line 55: | ||
[[Category:EMA approved in 2012]] | [[Category:EMA approved in 2012]] | ||
[[Category:FDA approved in 2011]] | [[Category:FDA approved in 2011]] | ||
| + | [[Category:Health Canada approved in 2012]] | ||
Revision as of 12:27, 31 March 2023
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.[1][2]
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
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[1]
- Crizotinib (Xalkori) patient drug information (Chemocare)[3]
- Crizotinib (Xalkori) patient drug information (UpToDate)[4]
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: Approved 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.
History of changes in Health Canada indication
- 2012-04-25: Initial notice of compliance with conditions
- 2015-11-18: Conditions were met
Also known as
- Code names: PF02341066, PF-02341066
- Brand name: Crizalk, Crizocap, Crizonix, Xalkori