Therapeutic Response

BRCA1 pathogenic variants status confers therapeutic sensitivity to Abiraterone acetate in combination with Niraparib and Prednisone in patients with Prostate Adenocarcinoma.

Statements

Source and description
Akeega (abiraterone acetate and niraparib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to Akeega (abiraterone acetate with niraparib) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for Akeega.
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.