BRCA1/2
9 EU-approved indications of 3 drugs need a BRCA1/2 result, in 4 tumour types, most of them in breast cancer, prostate cancer and ovarian cancer.
Approved indications9
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Breast cancer4 | ||||
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 |
| Pancreatic cancer1 | ||||
Lynparza | Germline BRCA1/2 mutation | Monotherapy | Maint. metastatic | After minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen without progression |
| Ovarian cancer1 | ||||
Lynparza | BRCA1/2 mutation (germline and/or somatic) | Monotherapy | Maint. advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy |
| Prostate cancer3 | ||||
Akeega | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone | 1L metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
Lynparza | BRCA1/2 mutation (germline and/or somatic) | Monotherapy | 2L metastatic | Castration-resistant only; After prior therapy that included a new hormonal agent; Castration-resistant |
Akeega | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone and androgen deprivation therapy (ADT) | Any line metastatic | Hormone-sensitive only |
BRCA1/2 by tumour
Label wording9
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Niraparib + abiraterone (Akeega)
in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
- Niraparib + abiraterone (Akeega)
for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
- Olaparib (Lynparza)
maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) 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.
- 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.
- Olaparib (Lynparza)
monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
- Olaparib (Lynparza)
as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
- 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.