Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Abiraterone acetate, Niraparib, Prednisolone in patients with Prostate Adenocarcinoma.
The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate in combination with prednisone or prednisolone 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.
This statement is based on a regulatory approval from the European Medicines Agency:
Akeega is indicated with prednisone or prednisolone 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.