Difference between revisions of "Fulvestrant (Faslodex)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Estrogen receptor antagonist; competitively binds to the estrogen receptor (ER) and downregulates estrogen receptor expression.<ref name="insert">[https://www.azpicentral.com/faslodex/faslodex.pdf Fulvestrant (Faslodex) package insert]</ref><ref>[[ | + | Class/mechanism: Estrogen receptor antagonist; competitively binds to the estrogen receptor (ER) and downregulates estrogen receptor expression.<ref name="insert">[https://www.azpicentral.com/faslodex/faslodex.pdf Fulvestrant (Faslodex) package insert]</ref><ref>[[:File:Fulvestrant.pdf|Fulvestrant (Faslodex) package insert (locally hosted backup)]]</ref><ref>[https://www.faslodex.com/ Faslodex manufacturer's website]</ref> |
<br>Route: IM | <br>Route: IM | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 15: | Line 15: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2002-04-25: Initial FDA approval for the treatment of [[Biomarkers#HR | hormone receptor]] [[Biomarkers#Expression|positive]] metastatic [[breast cancer]] in postmenopausal women with disease progression following [[Regimen_classes#Antiestrogen_therapy|antiestrogen therapy]]. ''(Based on Trial 0021 & Trial 0020)'' |
| − | * | + | * 2010-09-10: Approved at a dose of 500 mg for [[Biomarkers#HR | hormone receptor]] [[Biomarkers#Expression|positive]] metastatic [[breast cancer]] (full details missing). ''(Based on CONFIRM)'' |
| − | * | + | * 2016-03-02: Approved for the treatment of [[Biomarkers#HR |HR]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2 |human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] in combination with palbociclib in women with disease progression after [[Regimen_classes#Endocrine-based_regimen|endocrine therapy]]. ''(Based on PALOMA-3)'' |
| − | * 11 | + | * 2017-08-25: Approved for a new indication as monotherapy for the treatment of [[Biomarkers#HR|hormone receptor (HR)]] [[Biomarkers#Expression|positive]], [[Biomarkers#HER2 |human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced [[breast cancer]] in postmenopausal women not previously treated with endocrine therapy. ''(Based on FALCON)'' |
| − | * | + | * 2017-11-14: Approved for treatment of [[Biomarkers#HR |HR]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|HER2]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] in combination with abemaciclib in women with disease progression after [[Regimen_classes#Endocrine-based_regimen|endocrine therapy]]. ''(Based on MONALEESA-3)'' |
| + | * 2019-03-11: Approved for the treatment of [[Biomarkers#HR |HR]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|HER2]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] in postmenopausal women, in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. ''(Based on MONARCH 2)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2004-03-09: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2004-02-17: Initial notice of compliance | ||
| + | *Uncertain date: Indicated for treatment of estrogen receptor-positive, human epidermal growth receptor 2 (HER2)negative locally advanced or metastatic [[breast cancer]] in postmenopausal women not previously treated with endocrine therapy. | ||
| + | *Uncertain date: Indicated as hormonal treatment of locally advanced or metastatic [[breast cancer]] in postmenopausal women, regardless of age, who have disease progression following prior anti-estrogen therapy. | ||
| + | |||
| + | ==History of changes in PMDA indication== | ||
| + | *2011-09-26: Initial approval for the treatment of postmenopausal [[breast cancer]]. | ||
| + | *2017-09-27: Revised indication and a new dosage for the treatment of [[breast cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code | + | *'''Code names:''' ICI-182780, ZD-9238 |
*'''Brand names:''' Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol | *'''Brand names:''' Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol | ||
| Line 32: | Line 43: | ||
[[Category:Protein expression-specific medications]] | [[Category:Protein expression-specific medications]] | ||
| − | |||
[[Category:Estrogen receptor inhibitors]] | [[Category:Estrogen receptor inhibitors]] | ||
| Line 38: | Line 48: | ||
[[Category:FDA approved in 2002]] | [[Category:FDA approved in 2002]] | ||
| + | [[Category:EMA approved in 2004]] | ||
| + | [[Category:Health Canada approved in 2004]] | ||
| + | [[Category:PMDA approved in 2011]] | ||
Revision as of 00:12, 4 March 2024
General information
Class/mechanism: Estrogen receptor antagonist; competitively binds to the estrogen receptor (ER) and downregulates estrogen receptor expression.[1][2][3]
Route: IM
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
- Fulvestrant (Faslodex) package insert[1]
- Fulvestrant (Faslodex) patient drug information (Chemocare)[4]
- Fulvestrant (Faslodex) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2002-04-25: Initial FDA approval for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. (Based on Trial 0021 & Trial 0020)
- 2010-09-10: Approved at a dose of 500 mg for hormone receptor positive metastatic breast cancer (full details missing). (Based on CONFIRM)
- 2016-03-02: Approved for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy. (Based on PALOMA-3)
- 2017-08-25: Approved for a new indication as monotherapy for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (Based on FALCON)
- 2017-11-14: Approved for treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with abemaciclib in women with disease progression after endocrine therapy. (Based on MONALEESA-3)
- 2019-03-11: Approved for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (Based on MONARCH 2)
History of changes in EMA indication
- 2004-03-09: Initial authorization
History of changes in Health Canada indication
- 2004-02-17: Initial notice of compliance
- Uncertain date: Indicated for treatment of estrogen receptor-positive, human epidermal growth receptor 2 (HER2)negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
- Uncertain date: Indicated as hormonal treatment of locally advanced or metastatic breast cancer in postmenopausal women, regardless of age, who have disease progression following prior anti-estrogen therapy.
History of changes in PMDA indication
- 2011-09-26: Initial approval for the treatment of postmenopausal breast cancer.
- 2017-09-27: Revised indication and a new dosage for the treatment of breast cancer.
Also known as
- Code names: ICI-182780, ZD-9238
- Brand names: Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol