Johnson & Johnson's AKEEGA® Gets FDA Priority Review for BRCA-Mutated Prostate Cancer

FDA Priority Review

The U.S. FDA has granted Priority Review to Johnson & Johnson's supplemental New Drug Application for AKEEGA® (niraparib and abiraterone acetate) plus prednisone. This treatment targets patients with BRCA-mutated metastatic castration-sensitive prostate cancer (mCSPC), addressing a significant unmet medical need.

AMPLITUDE Study Findings

The Phase 3 AMPLITUDE study supports the application, showing that AKEEGA® plus prednisone reduced the risk of radiographic progression or death by 48% in patients with BRCA-mutated mCSPC. It also significantly prolonged the time to symptomatic progression by 56% and indicated a trend toward improved overall survival, with a 25% reduction in the risk of death.

Adverse Events

In the AMPLITUDE study, common Grade 3/4 adverse events for patients treated with AKEEGA® included anemia (53.9%) and hypertension (47.1%), compared to the abiraterone group.

Potential Impact

If approved, AKEEGA® would be the first PARP-based precision medicine combination for this patient group. Patients with BRCA mutations experience faster disease progression and shorter survival, highlighting the need for early genetic testing and novel therapies.

Study Details

AMPLITUDE is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual-action tablet with prednisone plus androgen deprivation therapy. The study enrolled 696 participants from 32 countries, focusing on radiographic progression-free survival as the primary endpoint.