# BRCA1/2 in breast cancer

4 EU-approved indications in breast cancer need a BRCA1/2 result: olaparib (adjuvant, early), olaparib (adjuvant, early), olaparib (advanced) and talazoparib (advanced).

## Approved indications

### BRCA1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | + endocrine therapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Advanced | After anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless not suitable; if HR-positive, progressed on or after prior endocrine therapy, or considered unsuitable for endocrine therapy |
| [Talazoparib](https://oncolabels.com/drugs/talazoparib) (Talzenna) | 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 |

## Label wording

- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, advanced: “monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **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)

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/breast-cancer/brca1-2