Difference between revisions of "Crizotinib (Xalkori)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *8/26/2011: [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]] | + | |
| − | *11/20/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm | + | ===[[Anaplastic large cell lymphoma]]=== |
| − | *3/11/2016: | + | *1/14/2021: Approved for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic [[Anaplastic large cell lymphoma|anaplastic large cell lymphoma (ALCL)]] that is [[Biomarkers#ALK|ALK]]-[Biomarkers#Rearrangement|positive]]. ''(New disease entity)'' |
| + | |||
| + | ===[[Non-small cell lung cancer]]=== | ||
| + | *8/26/2011: [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]]. | ||
| + | *11/20/2013: [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)'' | ||
| + | *3/11/2016: [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)'' | ||
==Also known as== | ==Also known as== | ||
Revision as of 15:44, 15 January 2021
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
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
- 1/14/2021: 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-[Biomarkers#Rearrangement|positive]]. (New disease entity)
Non-small cell lung cancer
- 8/26/2011: 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.
- 11/20/2013: 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)
- 3/11/2016: Approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. (New mutation-specific indication)
Also known as
- Code names: PF02341066, PF-02341066
- Brand name: Xalkori