Niraparib + abiraterone

Niraparib + abiraterone (Akeega) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BRCA1/2 (2).
Approved indications of Niraparib + abiraterone
Biomarker requirementRegimenSettingConditions
Prostate cancer2
Germline and/or somatic BRCA 1/2 mutations
+ prednisone or prednisolone
1L
metastatic
Castration-resistant only; Chemotherapy is not clinically indicated
Germline and/or somatic BRCA 1/2 mutations
+ prednisone or prednisolone and androgen deprivation therapy (ADT)
Any line
metastatic
Hormone-sensitive only
Full text of section 4.1 (therapeutic indications)

Akeega is indicated with prednisone or prednisolone:  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).  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.

Label history

2 changes to the Akeega label since 2025, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes