Difference between revisions of "Fulvestrant (Faslodex)"
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*2004-03-09: Initial authorization | *2004-03-09: Initial authorization | ||
==History of changes in PMDA indication== | ==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]]. | *2017-09-27: Revised indication and a new dosage for the treatment of [[breast cancer]]. | ||
==Also known as== | ==Also known as== | ||
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[[Category:FDA approved in 2002]] | [[Category:FDA approved in 2002]] | ||
[[Category:EMA approved in 2004]] | [[Category:EMA approved in 2004]] | ||
| + | [[Category:PMDA approved in 2011]] | ||
Revision as of 00:55, 10 June 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
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, ZD9238
- Brand names: Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol