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AKEEGA®

(niraparib and abiraterone acetate)

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AKEEGA® (niraparib and abiraterone acetate)
Medical Information

AKEEGA - Administration Without Androgen Deprivation Therapy (ADT)

Last Updated: 07/17/2026

SUMMARY

  • The efficacy and safety of the use of AKEEGA without androgen deprivation therapy (ADT) has not been established.
  • Evidence-based guidelines recommend using ADT to maintain castrate levels of serum testosterone (<50 ng/dL) even in patients with castration-resistant prostate cancer.1
  • In MAGNITUDE, the phase 3 study evaluating the efficacy and safety of AKEEGA with prednisone as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2, all patients received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy.2-5

Clinical Data

No clinical studies have been identified evaluating the use of AKEEGA without ADT for the treatment of patients with prostate cancer.

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) conducted on 29 June 2026 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.

 

References

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1 Advanced prostate cancer │ AUA/SUO guideline. Accessed 2026-06-29. Available via: https://www.auanet.org/
2 Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for treatment of participants with metastatic prostate cancer (MAGNITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 June 29]. Available via: https://clinicaltrials.gov/show/NCT03748641 NLM Identifier: NCT03748641.  
3 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.  
4 Chi KN, Sandhu S, Smith MR, et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol. 2023;34(9):772-782.  
5 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.  

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