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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)

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AKEEGA - Administration Without Prednisone

Last Updated: 06/24/2024

SUMMARY

The efficacy and safety of the use of AKEEGA without prednisone has not been established.
MAGNITUDE is an ongoing, phase 3 study evaluating the efficacy and safety of AKEEGA plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) mutations, including BRCA1/2.¹^-³

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 24 June 2024 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 2024 June 24]. 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	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.