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). At a median follow-up of 24.8 months at the second interim analysis, rPFS, as adjudicated by central review, demonstrated a consistent trend favoring Akeega plus prednisone, with a median rPFS of 19.5 months versus 10.9 months for placebo and abiraterone acetate plus prednisone (AAP).

There was also improvement seen in the secondary end points of time to symptomatic progression and time to initiation of cytotoxic chemotherapy for Akeega plus prednisone versus AAP alone. There was also a trend observed toward improvement in overall survival.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” Kim Chi, M.D., the principal investigator of the phase 3 MAGNITUDE study, said in a statement. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with Akeega and to help us understand how we can potentially achieve better health outcomes for patients.”

Approval of Akeega was granted to Janssen.

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