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).
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRCA1/2 mutation4 | ||||
Lynparza | Germline BRCA1/2 mutation, HER2-negative | + endocrine therapy | Adj. early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
Lynparza | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Adj. early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
Lynparza | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Any line 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 |
Talzenna | Germline BRCA1/2-mutations, HER2-negative | Monotherapy | Any line 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 |
See also
Label wording4
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Olaparib (Lynparza)
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).
- Olaparib (Lynparza)
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).
- Olaparib (Lynparza)
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.
- Talazoparib (Talzenna)
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.