The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer.
The approval makes Akeega the first and only dual action tablet combining a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor with abiraterone acetate, given with prednisone.
The FDA approval is based on positive results from the randomized multicenter phase 3 MAGNITUDE study. Patients treated with the combination of Akeega plus prednisone had a statistically significant risk reduction in radiographic progression-free survival (rPFS).
