Niraparib and abiraterone acetate (Akeega; Janssen Pharmaceutical Companies of Johnson & Johnson) is the first-and-only dual action tablet that combines a PARP inhibitor with abiraterone acetate administered with prednisone.
The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.
The combination, along with prednisone, is approved for adult patients with BRCA-positive castration-resistant prostate cancer, as determined by an FDA-approved test.