Niraparib/abiraterone acetate

Niraparib/abiraterone acetate
Combination of
NiraparibAntineoplastic agent
Abiraterone acetateHormone antagonist
Clinical data
Trade namesAkeega
License data
Routes of
administration		By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

Niraparib/abiraterone acetate, sold under the brand name Akeega, is a fixed-dose combination anti-cancer medication used for the treatment of prostate cancer.[2] It contains niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (antineoplastic agent), and abiraterone acetate, a CYP17 inhibitor (hormone antagonist).[2]

The most common side effects include anemia (low levels of red blood cells), high blood pressure, constipation, tiredness, nausea, thrombocytopenia (low levels of blood platelets), difficulty breathing, back pain, reduced appetite, neutropenia (low levels of neutrophils, a type of white blood cell), joint pain, vomiting, low levels of potassium, dizziness, difficulty sleeping, high blood glucose levels, and urinary tract infection.[2]ref name="FDA Akeega" />

Niraparib/abiraterone acetate was approved for medical use in the European Union in April 2023,[2] and in the United States in August 2023.[1][3][4]

Medical uses

In the European Union, niraparib/abiraterone is indicated for the treatment of adults with prostate cancer.[2] It is for people who have genetic mutations known as BRCA 1/2 mutations and who cannot have chemotherapy.[2] It is used in combination with prednisolone or another medicine prednisone, which is converted into prednisolone.[2]

In the United States, niraparib/abiraterone is indicated, in combination with prednisone, for adults with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer, as determined by an FDA-approved test.[1][3]

History

Efficacy was evaluated in cohort 1 of MAGNITUDE (NCT03748641), a randomized, double-blind, placebo-controlled trial enrolling 423 participants with homologous recombination repair (HRR) gene-mutated mCRPC.[3] Participants were randomized (1:1) to receive niraparib 200 mg and abiraterone acetate 1,000 mg plus prednisone 10mg daily or placebo and abiraterone acetate plus prednisone daily.[3] Participants were required to have a prior orchiectomy or be receiving gonadotropin-releasing hormone (GnRH) analogues.[3] Participants with mCRPC were eligible if they had not received prior systemic therapy in the mCRPC setting except for a short duration of prior abiraterone acetate plus prednisone (up to four months) and ongoing ADT.[3] Participants could have received prior docetaxel or androgen-receptor (AR) targeted therapies in earlier disease settings.[3] Randomization was stratified by prior docetaxel, prior AR targeted therapy, prior abiraterone acetate plus prednisone, and BRCA status.[3] Of the 423 participants enrolled, 225 (53%) had prospectively determined BRCA gene mutations (BRCAm).[3] No benefit was observed in mCRPC participants without an HRR gene mutation (Cohort 2 of MAGNITUDE) as the criterion for futility was met.[3]

Society and culture

On 23 February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Akeega, intended for the treatment of adults with metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations.[5] The applicant for this medicinal product is Janssen-Cilag International N.V.[5][6] Niraparib/abiraterone acetate was approved for medical use in the European Union in April 2023.[2] It was approved for use in the United States in August 2023, based on the Phase 3 MAGNITUDE study.[3][4]

References

  1. 1 2 3 "Akeega- niraparib tosylate monohydrate and abiraterone acetate tablet, film coated". DailyMed. 22 August 2023. Archived from the original on 24 August 2023. Retrieved 23 August 2023.
  2. 1 2 3 4 5 6 7 8 9 "Akeega EPAR". European Medicines Agency. 2 June 2023. Archived from the original on 3 June 2023. Retrieved 2 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. 1 2 3 4 5 6 7 8 9 10 11 "FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer". U.S. Food and Drug Administration (FDA). 11 August 2023. Retrieved 6 September 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 1 2 "U.S. FDA Approves Akeega (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer" (Press release). Janssen. 11 August 2023. Retrieved 17 August 2023 – via PR Newswire.
  5. 1 2 "Akeega: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ↑ "Janssen Receives Positive CHMP Opinion for Akeega (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer" (Press release). Janssen Pharmaceutica NV. 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023 – via GlobeNewswire.


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