Difference between revisions of "Ensartinib (Ensacove)"

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m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information")
 
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<br>Extravasation: n/a
 
<br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
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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.
  
==Preliminary data==
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==Diseases for which it is used==
===[[Non-small_cell_lung_cancer,_ALK-positive|ALK+ NSCLC]]===
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*[[Non-small_cell_lung_cancer,_ALK-positive|ALK+ NSCLC]]
#'''X396-CLI-101:''' Horn L, Infante JR, Reckamp KL, Blumenshein GR, Leal TA, Waqar SN, Gitlitz BJ, Sanborn RE, Whisenant JG, Du L, Neal JW, Gockerman JP, Dukart G, Harrow K, Liang C, Gibbons JJ, Holzhausen A, Lovly CM, Wakelee HA. Ensartinib (X-396) in ALK-positive non-small cell lung cancer: results from a first-in-human phase I/II, multicenter study. Clin Cancer Res. 2018 Jun 15;24(12):2771-2779. Epub 2018 Mar 21. [https://doi.org/10.1158/1078-0432.ccr-17-2398 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6004248/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29563138 PubMed] NCT01625234
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#'''eXalt3:''' Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1617-1625. [https://doi.org/10.1001/jamaoncol.2021.3523 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8414368/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34473194/ PubMed] NCT02767804
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==History of changes in NMPA indication==
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*2020-11-17: Initial approval for the second-line treatment of ALK-positive [[Non-small_cell_lung_cancer|NSCLC]] after progression or intolerance of crizotinib. ''(Based on X396-CLI-101)''
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*2022-03: Approved for the first-line treatment of ALK-positive [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]]. ''(Based on eXalt3)''
  
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' X-396
 
*'''Code name:''' X-396
 
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*'''Brand name:''' Ensacove
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
 
  
 
[[Category:ALK inhibitors]]
 
[[Category:ALK inhibitors]]
 
[[Category:ROS1 inhibitors]]
 
[[Category:ROS1 inhibitors]]
  
[[Category:Non-small cell lung cancer medications (investigational)]]
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[[Category:Non-small cell lung cancer medications]]
  
[[Category:Investigational drugs]]
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[[Category:NMPA approved in 2020]]

Latest revision as of 01:06, 29 June 2024

General information

Class/mechanism from the NCI Drug Dictionary: An orally available small molecule inhibitor of the receptor tyrosine kinase anaplastic lymphoma kinase (ALK) with potential antineoplastic activity. Upon oral administration, ensartinib binds to and inhibits ALK kinase, ALK fusion proteins and ALK point mutation variants. Inhibition of ALK leads to the disruption of ALK-mediated signaling and eventually inhibits tumor cell growth in ALK-expressing tumor cells.
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

History of changes in NMPA indication

  • 2020-11-17: Initial approval for the second-line treatment of ALK-positive NSCLC after progression or intolerance of crizotinib. (Based on X396-CLI-101)
  • 2022-03: Approved for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC). (Based on eXalt3)

Also known as

  • Code name: X-396
  • Brand name: Ensacove