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/2023/216793s000lbl.pdf. Revised August 2023. Accessed October 30, 2024.

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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BARD1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+)	BRIP1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+)	BRIP1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+)	CDK12 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisone