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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

AKEEGA® (niraparib and abiraterone acetate)

Medical Information

AKEEGA - Administration Without Prednisone

Last Updated: 07/10/2025

SUMMARY

The efficacy and safety of the use of AKEEGA without prednisone has not been established.
MAGNITUDE (NCT03748641)¹^,² and AMPLITUDE (NCT04497844)³^,⁴ are phase 3 studies evaluating the efficacy and safety of AKEEGA plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), respectively, with homologous recombination repair (HRR) mutations, including BRCA1/2.

Clinical Data

No clinical studies have been identified evaluating the use of AKEEGA without prednisone 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 01 July 2025 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.

References

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1	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 2025 June 11]. Available from: https://clinicaltrials.gov/show/NCT03748641 NLM Identifier: NCT03748641.
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.
3	Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for the treatment of participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) (AMPLITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 June 11]. Available from: https://clinicaltrials.gov/show/NCT04497844 NLM Identifier: NCT04497844.
4	Attard G, Agarwal N, Graff JN, et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. Oral Presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.

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