Difference between revisions of "Alectinib (Alecensa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12 | + | *2015-12-11: 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]]. ''(Based on [https://clinicaltrials.gov/ct2/show/NCT01588028 NP28761] and [https://clinicaltrials.gov/ct2/show/NCT01801111 NP28673])'' |
| − | *11 | + | *2017-11-06: 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; based on [https://clinicaltrials.gov/ct2/show/NCT02075840 ALEX])'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2017-02-16: Initial marketing authorization as Alecensa. |
| − | + | ==History of changes in Health Canada indication== | |
| + | *2016-09-28: Initial notice of compliance with conditions as Alecensaro. | ||
| + | *2018-09-26: Conditions were met | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y | *'''Code names:''' AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y | ||
| − | *'''Brand names:''' Alecensa, Alecinix, Alecnib | + | *'''Brand names:''' Alecensa, Alecensaro, Alecinix, Alecnib |
==References== | ==References== | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | |||
[[Category:ALK inhibitors]] | [[Category:ALK inhibitors]] | ||
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[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
| + | [[Category:FDA approved in 2015]] | ||
| + | [[Category:Health Canada approved in 2016]] | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
| − | |||
Revision as of 12:59, 29 March 2023
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
- 2015-12-11: 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)
- 2017-11-06: 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
- 2017-02-16: Initial marketing authorization as Alecensa.
History of changes in Health Canada indication
- 2016-09-28: Initial notice of compliance with conditions as Alecensaro.
- 2018-09-26: Conditions were met
Also known as
- Code names: AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y
- Brand names: Alecensa, Alecensaro, Alecinix, Alecnib