# BRCA1/2 in prostate cancer

3 EU-approved indications in prostate cancer need a BRCA1/2 result: niraparib + abiraterone (metastatic), niraparib + abiraterone (1st line, metastatic) and olaparib (2nd line, metastatic).

## Approved indications

### BRCA1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Niraparib + abiraterone](https://oncolabels.com/drugs/niraparib-abiraterone) (Akeega) | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | BRCA1/2 mutation (germline and/or somatic) | Monotherapy | 2nd line, metastatic | Castration-resistant only; After prior therapy that included a new hormonal agent; Castration-resistant |
| [Niraparib + abiraterone](https://oncolabels.com/drugs/niraparib-abiraterone) (Akeega) | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone and androgen deprivation therapy (ADT) | Metastatic | Hormone-sensitive only |

## Label wording

- **Niraparib + abiraterone** (Akeega), Prostate cancer, metastatic: “in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf)
- **Niraparib + abiraterone** (Akeega), Prostate cancer, 1st line, metastatic: “for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Prostate cancer, 2nd line, metastatic: “as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-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/tumours/prostate-cancer/brca1-2