Niraparib/abiraterone acetate, marketed as Akeega, is a fixed-dose combination anticancer medication taken orally alongside prednisone or prednisolone. Niraparib is a poly (ADP-ribose) polymerase, or PARP, inhibitor that blocks a DNA repair pathway cancer cells depend on, while abiraterone acetate is a CYP17 inhibitor that lowers androgen production. The combination is indicated for metastatic castration-resistant prostate cancer in adults who carry BRCA 1 or BRCA 2 gene mutations. Its efficacy was shown in the Phase 3 MAGNITUDE trial, which enrolled 423 participants with homologous recombination repair gene mutations. It was approved in the European Union in April 2023 and in the United States in August 2023. Common side effects include anemia, hypertension, fatigue, nausea and low blood cell counts.
Facts
Approved UseWith prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test 3 First Approved / Isolated Year Significant RiskMyelodysplastic syndrome/acute myeloid leukemia 3 Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration Connections
Sources
1. Niraparib/abiraterone acetate (Wikipedia)
Infobox drug, routes_of_administration
By mouth
Lead section, approval-status statement
Niraparib/abiraterone acetate was approved for medical use in the European Union in April 2023, and in the United States in August 2023.
View the Source2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
3. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer (FDA)
Opening paragraph, approval sentence
with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic
Prescribing information paragraph, warnings and precautions
The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia;
View the Source4. Drugs.com: Akeega (niraparib and abiraterone acetate) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Akeega (abiraterone acetate and niraparib) was first approved by the FDA on August 11, 2023
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