# Niraparib + abiraterone

Niraparib + abiraterone (Akeega) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BRCA1/2 (2).

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
| Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone and androgen deprivation therapy (ADT) | Metastatic | Hormone-sensitive only |

## Products

### Akeega

- Target: PARP and CYP17 inhibitor combination
- Class: Antineoplastic agents
- ATC: L01
- EU approval: 19 Apr 2023
- Label revised: 17 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/akeega-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/akeega

Mechanism (SmPC section 5.1): Niraparib inhibits PARP-1 and PARP-2 to impair DNA repair and trigger cell death, while abiraterone inhibits CYP17 to block androgen biosynthesis in testicular, adrenal, and prostatic tissues.

## 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)

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/niraparib-abiraterone