Difference between revisions of "Brigatinib (Alunbrig)"
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<br>Extravasation: n/a | <br>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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 13: | Line 13: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2017-04-28: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm Accelerated approval] for the treatment of patients with metastatic [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] who have progressed on or are intolerant to [[Crizotinib (Xalkori)|crizotinib]]. ''(Based on | + | *2017-04-28: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm Accelerated approval] for the treatment of patients with metastatic [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] who have progressed on or are intolerant to [[Crizotinib (Xalkori)|crizotinib]]. ''(Based on ALTA)'' |
| − | **2020-05-22: Full approval for adult patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]]. ''(Converted to regular approval and prior treatment requirement removed); based on | + | **2020-05-22: Full approval for adult patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]]. ''(Converted to regular approval and prior treatment requirement removed); based on ALTA-1L)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *2018-11-22: Initial authorization | + | *2018-11-22: Initial authorization as Alunbrig. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] previously treated with crizotinib. ''(Based on ALTA)'' |
| + | *2020-04-01: Extension of indication to include first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] previously not treated with an ALK inhibitor. ''(Based on ALTA-1L)'' | ||
==History of changes in Health Canada indication== | ==History of changes in Health Canada indication== | ||
*2018-07-26: Initial notice of compliance with conditions as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] who have progressed on or who were intolerant to an ALK inhibitor (crizotinib). | *2018-07-26: Initial notice of compliance with conditions as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] who have progressed on or who were intolerant to an ALK inhibitor (crizotinib). | ||
**2022-07-20: Conditions were met | **2022-07-20: Conditions were met | ||
*2021-03-03: New indication for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]]. | *2021-03-03: New indication for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]]. | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2021-01-22: Newly indicated for the treatment of unresectable advanced/recurrent anaplastic lymphoma kinase (ALK)-positive [[non-small cell lung cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' AP-26113 |
*'''Brand names:''' Alunbrig, Biganib, Briganix, Trepmac | *'''Brand names:''' Alunbrig, Biganib, Briganix, Trepmac | ||
| Line 45: | Line 47: | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
[[Category:Health Canada approved in 2018]] | [[Category:Health Canada approved in 2018]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Latest revision as of 01:06, 29 June 2024
General information
Class/mechanism: Tyrosine kinase inhibitor (TKI); inhibits multiple kinases including anaplastic lymphoma kinase (ALK), ROS1, insulin-like growth factor-1 receptor (IGF-1R), FLT-3, and EGFR deletion and point mutations. Brigatinib inhibited growth of cells with EML4-ALK and NPM-ALK fusion proteins. Brigatinib prevents autophosphorylation of ALK and, subsequently, downstream signaling through STAT3, AKT, ERK1/2, and S6. Brigatinib inhibited cells expressing EML4-ALK, as well as mutant forms of EML4-ALK, such as as G1202R and L1196M. Brigatinib was able to inhibit some mutant forms which are associated with resistance to ALK inhibitors including crizotinib, as well as EGFR-Del (E746-A750), ROS1-L2026M, FLT3-F691L, and FLT3-D835Y. [1][2][3]
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2017-04-28: Accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. (Based on ALTA)
- 2020-05-22: Full approval for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). (Converted to regular approval and prior treatment requirement removed); based on ALTA-1L)
History of changes in EMA indication
- 2018-11-22: Initial authorization as Alunbrig. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. (Based on ALTA)
- 2020-04-01: Extension of indication to include first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. (Based on ALTA-1L)
History of changes in Health Canada indication
- 2018-07-26: Initial notice of compliance with conditions as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).
- 2022-07-20: Conditions were met
- 2021-03-03: New indication for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).
History of changes in PMDA indication
- 2021-01-22: Newly indicated for the treatment of unresectable advanced/recurrent anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
Also known as
- Code name: AP-26113
- Brand names: Alunbrig, Biganib, Briganix, Trepmac