BRCA1/2 in triple-negative breast cancer
4 EU-approved indications in triple-negative 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 |
4 approvals for TNBC need no biomarker and apply whatever the result. All approvals for TNBC
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.