Difference between revisions of "Alectinib (Alecensa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12/11/2015: | + | *12/11/2015: Granted accelerated FDA approval for the treatment of patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] [[Contexts#Metastatic|metastatic]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] who have progressed on or are intolerant to [[Crizotinib (Xalkori)|crizotinib]]. |
| − | *11/6/2017: Granted regular FDA approval for treatment of patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]], as detected by an FDA-approved test. | + | *11/6/2017: Granted regular FDA approval for treatment of patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] [[Contexts#Metastatic|metastatic]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]], as detected by an FDA-approved test. ''(Converted to regular approval; prior crizotinib exposure requirement removed)'' |
==Also known as== | ==Also known as== | ||
Revision as of 01:43, 12 April 2021
General information
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.[1][2][3][4]
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.[1]
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.
- 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)
Also known as
- Code names: AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y
- Brand names: Alecensa, Alecinix, Alecnib