Therapeutic Response

BRCA2 oncogenic variants status confers therapeutic sensitivity to Abiraterone acetate in combination with Niraparib and Prednisolone in patients with Prostate Adenocarcinoma.

Statements

Source and description
Akeega (abiraterone acetate and niraparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate (Akeega) 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.
Akeega (abiraterone acetate and niraparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate (Akeega) in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline or somatic). This indication is based on the AMPLITUDE trial (NCT04497844), a phase 3, randomized, double-blind, placebo-controlled multinational study. Patients were required to have started ADT >= 14 days prior to randomization and have been willing to continue ADT throughout the treatment phase. Specific ADT was the choice of which was at the discretion of the investigator.