Crizotinib (Xalkori)

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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, 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

Anaplastic large cell lymphoma, pediatric

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

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 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: Crizalk, Crizocap, Crizonix, Xalkori