Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK). Alectinib and its metabolite M4 inhibit ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, which results in decreased growth of tumor cells which have ALK fusions, amplifications, or activating mutations.
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Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 12/11/2015: Granted accelerated FDA approval for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. (Based on NP28761 and NP28673)
- 11/6/2017: Granted regular FDA approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. (Converted to regular approval; prior crizotinib exposure requirement removed; based on ALEX)
History of changes in EMA indication
- 2/16/2017: Initial marketing authorization as Alecensa.
Also known as
- Code names: AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y
- Brand names: Alecensa, Alecinix, Alecnib