BRCA1/2 in prostate cancer
3 EU-approved indications in prostate cancer need a BRCA1/2 result: niraparib + abiraterone (metastatic), niraparib + abiraterone (1st line, metastatic) and olaparib (2nd line, metastatic).
Castration status
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRCA1/2 mutation3 | ||||
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 |
24 approvals for Prostate need no biomarker and apply whatever the result. All approvals for Prostate
See also
Label wording3
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)
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.