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.

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Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BRCA1 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+) BRCA1 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
Sensitivity (+) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone