WITH AKEEGA®,
IT'S A CLEAR TREATMENT PATH WITH AKEEGA®,THE ONLY FDA-APPROVED DUAL ACTION TABLET
FOR BRCA+ mCRPC
AKEEGA® is the first-and-only FDA-approved dual action tablet combining PARP inhibition and novel hormonal therapy to provide precision medicine for patients with BRCA+ mCRPC.1
Niraparib and abiraterone acetate (AKEEGA®) is a recommended treatment option by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for BRCA+ mCRPC2*†‡
- NCCN Category 1 for patients with no prior docetaxel or NHT
- NCCN Category 2A for patients with prior docetaxel and no prior NHT
- NCCN Category 2B for patients with prior NHT and no prior docetaxel
IMPROVED BENEFIT FOR
PATIENTS§ with 1L BRCA+
mCRPC vs placebo + AAP1||
PRECISION MEDICINE for BRCA+ mCRPC patients1
ONCE-DAILY DUAL
ACTION TABLETS1
‖AKEEGA® is indicated with 10 mg prednisone daily.1
AKEEGA® offers two drugs under one co-pay for BRCA+ mCRPC patients1
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*Niraparib plus abiraterone (combination tablet) is a treatment option for patients with metastatic CRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have not yet had treatment in the setting of metastatic CRPC, depending on prior treatment in other disease settings. Use of niraparib/abiraterone for those who have received prior NHT is controversial because a benefit of this combination over use of a PARP inhibitor alone has not been shown in this setting, but responses are likely. The fine particle formulation of abiraterone can be given with single-agent niraparib as a substitute for the combination niraparib/abiraterone tablet (category 2B; other recommended option).2
†See the NCCN Guidelines® for detailed recommendations, including other treatment options.2
‡Continue ADT to maintain castrate levels of serum testosterone (<50 ng/dL).2
§MAGNITUDE is a phase 3, randomized, double-blind, placebo controlled, multicenter study evaluating treatment with AKEEGA® vs standard of care (AAP). Cohort 1 consists of 423 subjects with mCRPC and HRR mutations, of which 225 subjects have BRCA mutations, who were randomized (1:1) to receive either AKEEGA® (n=212) or placebo + AAP once daily (n=211). AKEEGA® significantly reduced the risk of disease progression or death by 47% [HR = 0.53; 95% CI: 0.36, 0.79; P = 0.0014] in BRCA+ mCRPC patients.1,3
1L = first-line; AAP = abiraterone acetate (AA) + prednisone (P); ADT = androgen deprivation therapy; BRCA+ = BRCA gene-mutated; CI = confidence interval; HR = hazard ratio; HRR = homologous recombination repair; mCRPC = metastatic castration-resistant prostate cancer; NCCN = National Comprehensive Cancer Network® (NCCN®); NHT = novel hormonal therapy; PARP = poly (ADP-ribose) polymerase.
References:
- AKEEGA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed September 7, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way.
- 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;S0923-7534(23)00757-3. doi: 10.1016/j.annonc.2023.06.009
