# Talazoparib

Talazoparib (Talzenna, Pfizer Europe MA EEIG) has 2 EU-approved indications in 2 tumour types. 1 needs a biomarker result: BRCA1/2 (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Germline BRCA1/2-mutations, HER2-negative | Monotherapy | Advanced | Previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless not suitable; prior endocrine-based therapy for HR-positive breast cancer unless considered unsuitable |

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + enzalutamide | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |

## Products

### Talzenna

- Company: Pfizer Europe MA EEIG
- Target: PARP inhibitor
- Class: Poly (adp-ribose) polymerase (PARP) inhibitors
- ATC: L01XK04
- EU approval: 20 Jun 2019
- Label revised: 18 Jul 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/talzenna-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna

Mechanism (SmPC section 5.1): Inhibits PARP1 and PARP2 catalytic activity and traps PARP on DNA lesions, preventing DNA repair and inducing apoptosis.

## Label wording

- **Talazoparib** (Talzenna), Breast cancer, advanced: “Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf)
- **Talazoparib** (Talzenna), Prostate cancer, 1st line, metastatic: “Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/talzenna-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/talazoparib