# Abiraterone

Abiraterone (Abiraterone Krka, Zytiga) has 3 EU-approved indications in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
| None | + prednisone or prednisolone, and androgen deprivation therapy (ADT) | 1st line, metastatic | Hormone-sensitive only; Newly diagnosed; high risk |
| None | + prednisone or prednisolone | 2nd line, metastatic | Castration-resistant only; Progressed on or after a docetaxel-based chemotherapy regimen |

## Products

### Abiraterone Krka

- Company: Krka, d.d., Novo mesto
- Target: CYP17 inhibitor (androgen biosynthesis inhibitor)
- Class: Other hormone antagonists and related agents
- ATC: L02BX03
- EU approval: 24 Jun 2021
- Label revised: 16 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/abiraterone-krka-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/abiraterone-krka-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-krka
- Biosimilars and generics: Abiraterone Mylan

Mechanism (SmPC section 5.1): Abiraterone selectively inhibits CYP17 (17α-hydroxylase/C17,20-lyase), blocking androgen biosynthesis in testicular, adrenal and prostatic tumour tissue and lowering serum testosterone.

### Zytiga

- Company: Janssen-Cilag International
- Target: CYP17 inhibitor (androgen biosynthesis inhibitor)
- Class: Other hormone antagonists and related agents
- ATC: L02BX03
- EU approval: 5 Sep 2011
- Label revised: 18 Oct 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zytiga-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga
- Biosimilars and generics: Abiraterone Accord

Mechanism (SmPC section 5.1): Abiraterone selectively inhibits CYP17 (17α-hydroxylase/C17,20-lyase), blocking androgen synthesis in testes, adrenals and prostate tumour; with LHRH analogues it drops testosterone to undetectable levels.

## Label wording

- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 1st line, metastatic: “the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf)
- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 1st line, metastatic: “the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf)
- **Abiraterone** (Zytiga, Abiraterone Krka), Prostate cancer, 2nd line, metastatic: “the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zytiga-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/abiraterone