# Rucaparib

Rucaparib (Rubraca, pharmaand GmbH) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Ovarian cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Maintenance, advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy |
| None | Monotherapy | Maintenance, advanced | High-grade only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy |

## Products

### Rubraca

- Company: pharmaand GmbH
- Target: PARP inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX
- EU approval: 23 May 2018
- Label revised: 27 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/rubraca-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/rubraca

Mechanism (SmPC section 5.1): Inhibits PARP enzymatic activity and traps PARP-DNA complexes, resulting in increased DNA damage, apoptosis, and cell death.

## Label wording

- **Rucaparib** (Rubraca), Ovarian cancer, maintenance, advanced: “Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf)
- **Rucaparib** (Rubraca), Ovarian cancer, maintenance, advanced: “Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rubraca-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/rucaparib