Launch
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
What's New: Drugs RSS Feed · By FDA ·
The Brief
- On December 12, 2025, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone.
- The approval covers adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer.
Why it matters
It adds a targeted combination treatment option for a defined genetic subgroup of metastatic prostate cancer patients, which matters for oncology researchers and clinicians tracking precision-medicine approvals.
Who’s affected
- Adults with BRCA2-mutated metastatic castration-sensitive prostate cancer
- #prostate-cancer
- #brca2
- #fda
- #drug-approval
- #oncology
- #precision-medicine
On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer.
Timeline
FDA approves niraparib and abiraterone acetate with prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
What's New: Drugs RSS Feed
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer