Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) granted approval to Akeega (abiraterone acetate with niraparib) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for Akeega.

This is written in the approval document as:

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.

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.

Therapeutic response

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

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