Regulatory approval

Published by the Food and Drug Administration. Approved

AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC). Select patients for therapy based on an FDA-approved test for AKEEGA.

This is written in the approval document.

Citation

Janssen Biotech, Inc. Akeega (abiraterone acetate and niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf. Revised December 2025. Accessed February 5, 2026.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
FDA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone