Crizotinib (Xalkori)

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.
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.

Diseases for which it is used

• ALK+ non-small cell lung cancer
• ROS1+ non-small cell lung cancer

Patient drug information

• Crizotinib (Xalkori) package insert pages 15-18
• Crizotinib (Xalkori) patient drug information (Chemocare)
• Crizotinib (Xalkori) patient drug information (UpToDate)

History of changes in FDA indication

• 8/26/2011: Initial FDA 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