Fulvestrant
Also known as: Faslodex · Fulvestrant Mylan · CLIGAVYX
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, fulvestrant is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women who have not been previously treated with endocrine therapy, or who have disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. In the European Union, it is also indicated in combination with palbociclib for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who received prior endocrine therapy, which should be combined with a luteinizing hormone releasing hormone agonist in pre- or perimenopausal women. In the United States, fulvestrant is indicated as monotherapy for HR-positive, HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or for HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. In the United States, it is also indicated in combination with ribociclib for HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women as initial endocrine-based therapy or following disease progression, and in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
From: Source: European Medicines Agency (EMA), Faslodex — EPAR, 15/05/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 282357 fulvestrant
- EMA
- EMEA/H/C/000540, EMEA/H/C/004649
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
FDA (USA) CLIGAVYX
1 INDICATIONS AND USAGE Monotherapy CLIGAVYX is indicated 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, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy CLIGAVYX is indicated 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. HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. CLIGAVYX is an estrogen receptor antagonist indicated 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. ( 1 ) HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. ( 1 ) 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. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. ( 1 )
Data provided by the U.S. Food and Drug Administration.
Document date: 20260624 · Official document →
EMA (EU) Faslodex
Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Source: European Medicines Agency (EMA), Faslodex — EPAR, 15/05/2025. © European Medicines Agency.
Document date: 15/05/2025 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Fulvestrant approved for in the European Union?
Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. (Source: European Medicines Agency (EMA), Faslodex — EPAR, 15/05/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Data provided by the U.S. Food and Drug Administration.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Faslodex — EPAR, 15/05/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
In an emergency, call 112 (or your local emergency number). Do not delay seeking medical help because of something you read here.