Difference between revisions of "Eribulin (Halaven)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 2010-11-15: Initial | + | * 2010-11-15: Initial approval for the treatment of patients with metastatic [[Breast cancer | breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an [[Regimen_classes#Anthracycline-based_regimen|anthracycline]] and a [[Regimen_classes#Taxane-based_regimen|taxane]] in either the adjuvant or metastatic setting. ''(Based on EMBRACE)'' |
| − | * 2016-01-28: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm483795.htm | + | * 2016-01-28: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm483795.htm Approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on E7389-G000-309)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2011-03-17: Initial marketing authorization as Halaven. | *2011-03-17: Initial marketing authorization as Halaven. | ||
| − | + | ==History of changes in Health Canada indication== | |
| + | *2011-12-14: Initial notice of compliance for the treatment of patients with metastatic [[breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting. | ||
| + | *2017-08-04: New indication for the treatment of adult patients with an unresectable advanced or metastatic [[liposarcoma]] subtype of soft tissue sarcoma. Prior therapy should have included an anthracycline-containing regimen, unless not clinically appropriate. | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' E7389, ER-086526, NSC-707389 | *'''Code names:''' E7389, ER-086526, NSC-707389 | ||
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[[Category:EMA approved in 2011]] | [[Category:EMA approved in 2011]] | ||
[[Category:FDA approved in 2010]] | [[Category:FDA approved in 2010]] | ||
| + | [[Category:Health Canada approved in 2011]] | ||
Revision as of 00:22, 10 May 2023
General information
Class/mechanism: Non-taxane microtubule dynamics inhibitor. Inhibits the growth phase of microtubules and aggregates tubulin into inactive aggregates. Does not affect the shortening phase. Disruption of mitotic spindles interferes with mitosis, leads to G2/M cell-cycle block, and apoptotic cell death.[1][2][3]
Route: IV
Extravasation: no information
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
- Eribulin (Halaven) package insert[1]
- Eribulin (Halaven) patient drug information (Chemocare)[4]
- Eribulin (Halaven) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2010-11-15: Initial approval for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (Based on EMBRACE)
- 2016-01-28: Approved for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (Based on E7389-G000-309)
History of changes in EMA indication
- 2011-03-17: Initial marketing authorization as Halaven.
History of changes in Health Canada indication
- 2011-12-14: Initial notice of compliance for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.
- 2017-08-04: New indication for the treatment of adult patients with an unresectable advanced or metastatic liposarcoma subtype of soft tissue sarcoma. Prior therapy should have included an anthracycline-containing regimen, unless not clinically appropriate.
Also known as
- Code names: E7389, ER-086526, NSC-707389
- Generic name: eribulin mesylate
- Brand name: Brutravon, Ebunat, Epbriv, Halaven, Mitobulin, Rayldeima, Teceris