Key highlights
- FDA approved AKEEGA for BRCA2-mutated metastatic castration-sensitive prostate cancer.
- AKEEGA combines niraparib and abiraterone acetate with prednisone.
- Clinical trials showed a 54% reduction in disease progression risk.
- Common side effects include decreased hemoglobin and musculoskeletal pain.
FDA Approval
The U.S. FDA has approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate with prednisone, for treating BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
Clinical Trial Results
The approval is based on the AMPLITUDE Phase 3 clinical study, which demonstrated a 54% reduction in the risk of radiographic progression or death compared to the standard of care. The study also showed a 59% delay in symptomatic progression.
Safety Profile
The safety profile of AKEEGA plus prednisone aligns with known profiles of each monotherapy. Common adverse reactions include decreased hemoglobin, decreased lymphocytes, musculoskeletal pain, and fatigue.
