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 BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). 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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
FDA (2)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
FDA (2)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
FDA (2)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-08-11	Food and Drug Administration	Indication received traditional approval.