Brand: Akeega

Initial US Approval

  • 2023 (BRCA-mutated mCRPC, August 11, 2023). Expanded December 12, 2025, to BRCA2-mutated mCSPC.1,5,6

Indications

BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer:

  • With prednisone, for adult patients with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) mCSPC.1

BRCA-Mutated mCRPC:

  • With prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) mCRPC.1
  • Patient selection: select patients based on an FDA-approved test (BRCA2 alteration for mCSPC; BRCA alteration for mCRPC). FoundationOne CDx (tissue, 2023) and FoundationOne Liquid CDx (plasma, 2024) are the companion diagnostics for mCRPC.1,7

Recommended Dose/Route

  • 200 mg niraparib/1000 mg abiraterone acetate orally once daily (two 100 mg/500 mg tablets) on an empty stomach, at least 1 hour before or 2 hours after food, until disease progression or unacceptable toxicity.1
  • Prednisone: 5 mg once daily for mCSPC; 10 mg once daily for mCRPC. Patients should also receive a GnRH analog concurrently or should have had bilateral orchiectomy.1

Dose Reductions for Adverse Reactions

Figure

Pivotal Study

AMPLITUDE (NCT04497844)

  • Key Inclusion Criteria: mCSPC with an HRR gene alteration; up to 6 months of prior ADT, 45 days of abiraterone, and 6 cycles of docetaxel allowed.1,4
  • Treatment: 696 patients randomized 1:1, double blind, to niraparib/abiraterone acetate plus prednisone 5 mg or placebo plus abiraterone acetate and prednisone. BRCA2-mutated subgroup: 162 vs 161.1

MAGNITUDE (NCT03748641)

  • Key Inclusion Criteria: first-line mCRPC with an HRR gene alteration (cohort 1, n=423); up to 4 months of prior abiraterone for mCRPC allowed.1,2
  • Treatment: randomized 1:1, double blind, niraparib/abiraterone acetate plus prednisone 10 mg vs placebo plus abiraterone acetate and prednisone. BRCA-mutated subgroup: 113 vs 112.1
Figure
  • Fair balance: the AMPLITUDE BRCA2 result is a subgroup analysis that FDA described as exploratory, and OS is immature. MAGNITUDE OS in the BRCA-mutated subgroup was not statistically significant, and no benefit was seen with non-BRCA HRR alterations.1,3,5

Safety

AMPLITUDE, BRCA2-Mutated mCSPC (N=162)

  • Summary: serious adverse reactions 36%, fatal 4.9%, discontinuation 13%, dose reduction 25%, dose interruption 67%.1
  • Key warnings: myelodysplastic syndrome/acute myeloid leukemia (0.6%); myelosuppression (grade 3 or 4 anemia 29%; transfusion in 25% of patients with anemia); hypokalemia, fluid retention, and cardiovascular reactions (grade 3 or 4 hypertension 30%); hepatotoxicity; adrenocortical insufficiency; hypoglycemia; increased fractures and mortality with radium Ra 223; posterior reversible encephalopathy syndrome; embryo-fetal toxicity.1
Figure

MAGNITUDE, BRCA-Mutated mCRPC (N=113)

  • Summary: serious adverse reactions 41%, fatal 9% (COVID-19, 5%), discontinuation 15%, dose reduction 28%, dose interruption 50%. Most common adverse reactions: musculoskeletal pain 44%, fatigue 43%, constipation 34%, nausea 33%, hypertension 33%; laboratory, decreased hemoglobin 67%, lymphocytes 55%, platelets 37%.1

References

  1. Akeega (niraparib and abiraterone acetate) tablets. Prescribing information. Janssen Biotech, Inc; revised 12/2025. Accessed October 2026.
  2. Chi KN, Rathkopf D, Smith MR, et al. Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351. doi:10.1200/JCO.22.01649
  3. Chi KN, Castro E, Attard G, et al. Niraparib and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: final overall survival analysis for the phase 3 MAGNITUDE trial. Eur Urol Oncol. 2025;8(4):986-998. doi:10.1016/j.euo.2025.04.012
  4. Attard G, Agarwal N, Graff JN, et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025;31(12):4109-4118. doi:10.1038/s41591-025-03961-8
  5. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. US Food and Drug Administration. December 12, 2025.
  6. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer. US Food and Drug Administration. August 11, 2023.
  7. Janssen Medical Information. Akeega: HRR mutations and companion diagnostic (CDx) overview. Updated December 29, 2025. Accessed October 2026.