Akeega (abiraterone acetate and niraparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	4
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
FDA (1)	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