47%

reduced risk of disease progression or death vs placebo + AAP1,4
HR, 0.53 (95% CI, 0.36-0.79); P=0.0014

Efficacy
pills icon

Once-daily
dual action tablets under 1 co-pay
1*

Dosing
85%

of patients with BRCAm mCRPC remained on AKEEGA® without discontinuing due to ARs1

Safety

MAGNITUDE: A phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluated AKEEGA® with prednisone (n=113) against standard of care AAP (n=112) in patients with BRCA mutations.1,2,4

Trial Design

Permanent discontinuation of any component of AKEEGA® due to an adverse reaction occurred in 15% of patients. Adverse reactions which resulted in permanent discontinuation of AKEEGA in >2% of patients included COVID-19 (4.4%), anemia (2.7%), asthenia (2.7%), and vomiting (2.7%).

*AKEEGA® offers simplified dosing in a dual action tablet that combines PARPi and NHT. The recommended AKEEGA® dose is 200 mg niraparib/1,000 mg abiraterone acetate (2 tablets, once daily).1

AAP, abiraterone acetate (AA) + prednisone (P); AR, adverse reaction; BRCAm, BRCA gene-mutated; CI, confidence interval; FDA, U.S. Food and Drug Administration; HR, hazard ratio; mCRPC, metastatic castration-resistant prostate cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NHT, novel hormonal therapy; PARPi, poly (ADP-ribose) polymerase inhibitor.

References:

  1. AKEEGA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  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, 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. doi:10.1016/j.annonc.2023.06.009
  4. 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 III MAGNITUDE trial. Eur Urol Oncol. Published online May 5th, 2025. doi:10.1016/j.euo.2025.04.012