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Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Akeega (abiraterone/niraparib) (CYP17A1 inhibitor, PARP1 inhibitor, PARP2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Janssen's prostate cancer drug Akeega arrives in Korea
Published date:
09/26/2023
Excerpt:
...Ministry of Food and Drug Safety (MFDS) approved Akeega as a combination therapy with prednisolone in treating adult patients who have not received chemotherapy after diagnosis of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
Secondary therapy:
prednisolone
Source:
Title:
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer
Published date:
08/11/2023
Excerpt:
Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
Source:
Title:
Health Canada Authorizes AKEEGA™ (niraparib and abiraterone acetate) Dual Action Tablets for Targeted Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with BRCA (1/2) Gene Mutations
Published date:
06/14/2023
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance with conditions (NOC/c) for AKEEGA™ (niraparib and abiraterone acetate) tablets, plus prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC)...The approval with conditions is based on a clinically meaningful radiographic progression-free survival (rPFS), time to symptomatic progression (TSP) and time to cytotoxic chemotherapy (TCC) with continued approval contingent upon the verification and description of clinical benefit from the final OS analyses.
Secondary therapy:
prednisolone; prednisone
Source:
Title:
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
Published date:
04/21/2023
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
Secondary therapy:
prednisolone; prednisone
Source:
Title:
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
Published date:
02/24/2023
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated....The positive CHMP opinion is based on results of the randomised, double-blind, placebo controlled, Phase 3 MAGNITUDE study...
Secondary therapy:
prednisolone; prednisone
