Difference between revisions of "Fulvestrant (Faslodex)"
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==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)'' |
* Uncertain date: Approved at a dose of 500 mg for [[Biomarkers#HR | hormone receptor]] [[Biomarkers#Expression|positive]] metastatic [[breast cancer]] (full details missing). ''(Based on CONFIRM)'' | * Uncertain date: 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)'' |
| − | * | + | * 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)'' |
| − | * 11 | + | * 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== | ==History of changes in EMA indication== | ||
| − | * | + | *2004-03-09: Initial authorization |
==Also known as== | ==Also known as== | ||
*'''Code names:''' ICI 182780, ZD9238 | *'''Code names:''' ICI 182780, ZD9238 | ||
Revision as of 22:02, 4 May 2023
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)
- Uncertain date: 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
Also known as
- Code names: ICI 182780, ZD9238
- Brand names: Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol