# Toremifene

Toremifene (Fareston, Orion Corporation) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: Hormone receptor (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive | Monotherapy | 1st line, metastatic | Postmenopausal |

## Products

### Fareston

- Company: Orion Corporation
- Target: Selective estrogen receptor modulator
- Class: Anti-estrogens
- ATC: L02BA02
- EU approval: 14 Feb 1996
- Label revised: 30 Jul 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/fareston-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/fareston-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/fareston

Mechanism (SmPC section 5.1): Binds specifically and competitively to estrogen receptors, inhibiting estrogen-induced DNA synthesis and cell replication to exert an anti-estrogenic antitumor effect.

## Label wording

- **Toremifene** (Fareston), Breast cancer, 1st line, metastatic: “First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with estrogen receptor negative tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fareston-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/toremifene