# Radium Ra223 dichloride

Radium Ra223 dichloride (Xofigo, Bayer AG) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + LHRH analogue | Metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |
| None | Monotherapy | Metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |

## Products

### Xofigo

- Company: Bayer AG
- Target: Alpha particle-emitting radiopharmaceutical
- ATC: V10XX03
- EU approval: 13 Nov 2013
- Label revised: 30 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/xofigo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/xofigo

Mechanism (SmPC section 5.1): Mimics calcium to form complexes with hydroxyapatite in bone metastases, emitting high linear energy transfer alpha particles that cause lethal double-strand DNA breaks in adjacent tumor cells.

## Label wording

- **Radium Ra223 dichloride** (Xofigo), Prostate cancer, metastatic: “Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf)
- **Radium Ra223 dichloride** (Xofigo), Prostate cancer, metastatic: “Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xofigo-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/radium-ra223-dichloride