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.
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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