Ensartinib (Ensacove)

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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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), 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