AKEEGA™ (niraparib and abiraterone acetate)

FOR IMMEDIATE RELEASE:

AKEEGA™ (niraparib and abiraterone acetate) Now Available from Onco360 For the Treatment of Adult Patients with Deleterious or Suspected Deleterious BRCA-mutated (BRCAm) Metastatic Castration-Resistant Prostate Cancer (mCRPC) in Combination with Prednisone

Louisville, KY — October 2, 2023 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by The Janssen Pharmaceutical Companies of Johnson & Johnson for AKEEGA™ (niraparib and abiraterone acetate). AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor, indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for AKEEGA. Patients taking AKEEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

“Onco360 is thankful for the opportunity to partner with the team at Janssen and become a specialty pharmacy provider for AKEEGA,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add another treatment option for our prostate cancer patients who have metastatic disease, are no longer responding to androgen deprivation therapy (ADT), and who have applicable BRCA mutations to our already strong portfolio of prostate cancer medications.”

Based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, approximately 288,300 men will be diagnosed with prostate cancer in 2023, accounting for 14.7% of all new cancer cases, with approximately 34,700 expected patient deaths from prostate cancer in 2023, accounting for 5.7% of all cancer deaths. The five-year relative survival for prostate cancer when considering all stages of disease is 97.1%.¹ mCRPC is defined by disease progression despite castrate levels of testosterone with the appearance of new metastatic disease.²  Approximately 12% of adult males with mCRPC harbor a deleterious BRCA1 or BRCA2 gene alteration. Additionally, adult males with a germline BRCA alteration have an increased risk for prostate cancer and more commonly have lymph node involvement and/or distant metastatic disease.^3,4,5

AKEEGA is manufactured by Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The FDA approval for AKEEGA is based on the results of a 225 patient BRCAm mCRPC subgroup of the Phase III MAGNITUDE Trial (NCT03748641), a randomized double blind, placebo-controlled, multi-cohort, multi-center study in which 423 patients with homologous recombination repair (HRR) gene-mutated (HRRm) mCRPC were randomized (1:1) to receive niraparib 200 mg and abiraterone acetate 1000 mg (AKEEGA) or placebo and abiraterone acetate 1000 mg until unacceptable toxicity or progression. All patients received prednisone 10 mg daily and a GnRH analog or had prior bilateral orchiectomy. In the BRCAm mCRPC subgroup, AKEEGA plus prednisone administration resulted in a 47% reduction in risk of progression or death (radiographic progression-free survival [rPFS] hazard ratio [HR] 0.53; 95% CI, 0.36, 0.79 ; P = 0.0014) compared to placebo and abiraterone acetate plus prednisone.⁶

Please see the full Prescribing Information for AKEEGA^™.

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Media Contact:

Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

1. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed August 23rd, 2023:  https://seer.cancer.gov/statfacts/html/prost.html
2. Saad F, Chi KN, Finelli A, et al: The 2015 CUA-CUOG guidelines for the management of castration-resistant prostate cancer (CRPC). Can Urol Assoc J 9:90-96, 2015
3. Abida W, Armenia J, Gopalan A, et al: Prospective genomic profiling of prostate cancer across disease states reveals germline and somatic alterations that may affect clinical decision making. JCO Precis Oncol 2017:1-16, 2017
4. Castro E, Goh C, Olmos D, et al: Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. J Clin Oncol 31:1748-1757, 2013
5. Bancroft EK, Page EC, Castro E, et al: Targeted prostate cancer screening in BRCA1 and BRCA2 mutation carriers: Results from the initial screening round of the IMPACT study. Eur Urol 66:489-499, 2014 [Erratum: Eur Urol 67:e126, 2015] AKEEGA™
6. Prescribing Information. Accessed August 23, 2023.

Trademarks:

Johnson & Johnson, Inc., AKEEGA™ and associated logos are registered trademarks of Johnson & Johnson, Inc.