Difference between revisions of "Alectinib (Alecensa)"
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==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2014-07-04: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive [[non-small cell lung cancer]]. | *2014-07-04: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive [[non-small cell lung cancer]]. | ||
| − | *2020-02-21: | + | *2020-02-21: New indication and a new dosage for the treatment of relapsed or refractory ALK fusion gene-positive [[anaplastic large cell lymphoma]]. |
==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 | ||
Revision as of 01:53, 11 June 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 Clinical Trial Registry NP28761] and Clinical Trial Registry 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 Clinical Trial Registry 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 a monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
- 2018-09-26: Conditions were met for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
- 2018-06-11: New indication for the first-line treatment of patients with anaplastic lymphoma kinase-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer.
History of changes in PMDA indication
- 2014-07-04: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive non-small cell lung cancer.
- 2020-02-21: New indication and a new dosage for the treatment of relapsed or refractory ALK fusion gene-positive anaplastic large cell lymphoma.
Also known as
- Code names: AF802, AF-802, CH5424802, RG7853, RO5424802, UNII-LIJ4CT1Z3Y
- Brand names: Alecensa, Alecensaro, Alecinix, Alecnib