Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Abiraterone acetate, Niraparib, Prednisone in patients with Prostate Adenocarcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
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 or somatic).