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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 Androgen Deprivation Therapy (ADT)

Last Updated: 07/19/2024

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 17 July 2024 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.

References

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1	Lowrance W, Breau R, Chou R, et al. Advanced prostate cancer: AUA/SUO guideline. Accessed: July 19, 2024. Available from: 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 2024 July 15]. Available from: 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 K, Castro E, Attard G, et al. Niraparib (NIRA) with abiraterone acetate plus prednisone (AAP) as first-line (1L) therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: three-year update and final analysis (FA) of MAGNITUDE. Oral presentation presented at: European Society of Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.