# Degarelix

Degarelix (Firmagon, Ferring Pharmaceuticals A/S) has 3 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Neoadjuvant | High-risk localised or locally advanced; hormone-dependent disease |
| None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone-dependent disease |
| None | Monotherapy | Advanced | Hormone-dependent disease |

## Products

### Firmagon

- Company: Ferring Pharmaceuticals A/S
- Target: GnRH receptor antagonist
- Class: Other hormone antagonists and related agents
- ATC: L02BX02
- EU approval: 17 Feb 2009
- Label revised: 30 Mar 2022
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/firmagon-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/firmagon
- Biosimilars and generics: Degarelix Accord

Mechanism (SmPC section 5.1): Competitively and reversibly binds pituitary GnRH receptors, rapidly reducing LH and FSH release and thereby testicular testosterone secretion, without an initial testosterone surge.

## Label wording

- **Degarelix** (Firmagon), Prostate cancer, advanced: “for treatment of adult male patients with advanced hormone-dependent prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf)
- **Degarelix** (Firmagon), Prostate cancer, any line: “for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf)
- **Degarelix** (Firmagon), Prostate cancer, neoadjuvant: “as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/firmagon-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/degarelix