Difference between revisions of "Crizotinib (Xalkori)"

Revision as of 04:42, 12 January 2020

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

History of changes in FDA indication

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 as detected by an FDA-approved test.
11/20/2013: FDA approval revised for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
3/11/2016: FDA approval expanded for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

Also known as

Code names: PF02341066, PF-02341066
Brand name: Xalkori

References

[insert-1] 1.0 ^1.1 ^1.2 Crizotinib (Xalkori) package insert

[2] Crizotinib (Xalkori) package insert (locally hosted backup)

[3] Crizotinib (Xalkori) patient drug information (Chemocare)

[4] Crizotinib (Xalkori) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

@@ Line 16: / Line 16: @@
 ==History of changes in FDA indication==
-*8/26/2011: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm Initial FDA approval] "for the treatment of patients with locally advanced or metastatic [[Non-small_cell_lung_cancer#Advanced_or_metastatic_disease.2C_ALK-positive | non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive]] as detected by an FDA-approved test."
+*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]] as detected by an FDA-approved test.
-*11/20/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm FDA approval revised] "for the treatment of patients with metastatic [[Non-small_cell_lung_cancer#Advanced_or_metastatic_disease.2C_ALK-positive | non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive]] as detected by an FDA-approved test."
+*11/20/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm FDA approval revised] 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]] as detected by an FDA-approved test.
-*3/11/2016: FDA approval [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm490391.htm expanded] "for the treatment of patients with metastatic [[Non-small_cell_lung_cancer,_ROS1-positive|non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive]]."
+*3/11/2016: FDA approval [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm490391.htm expanded] 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]].
 ==Also known as==