# Fulvestrant

Fulvestrant (Faslodex, AstraZeneca AB) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (3).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive | Monotherapy | 1st line, advanced | No prior endocrine therapy; Postmenopausal women |
| Hormone receptor-positive, HER2-negative | + palbociclib | 2nd line, advanced | After prior endocrine therapy; Women; In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a LHRH agonist |
| Hormone receptor-positive | Monotherapy | 2nd line, advanced | Disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy; Postmenopausal women |

## Products

### Faslodex

- Company: AstraZeneca AB
- Target: Selective estrogen receptor degrader
- Class: Anti-estrogens
- ATC: L02BA03
- EU approval: 9 Mar 2004
- Label revised: 15 May 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/faslodex-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/faslodex
- Biosimilars and generics: Fulvestrant Mylan

Mechanism (SmPC section 5.1): Competitive estrogen receptor antagonist that blocks the trophic actions of estrogens without partial agonist activity and downregulates estrogen receptor protein levels.

## Label wording

- **Fulvestrant** (Faslodex), Breast cancer, 1st line, advanced: “• 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” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)
- **Fulvestrant** (Faslodex), Breast cancer, 2nd line, advanced: “• 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)
- **Fulvestrant** (Faslodex), Breast cancer, 2nd line, advanced: “• 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 (see section 5.1).
In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/fulvestrant