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# FDA Grants Priority Review to J&J’s Akeega sNDA
- URL: https://www.fdaweb.com/fda-grants-priority-review-to-j-js-akeega-snda/
- Published: 2025-10-16T12:00:00.000Z
- Updated: 2026-09-14T15:24:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160051

FDA has accepted for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone for treating BRCA-mutated metastatic castration-sensitive prostate cancer. If approved, the company says the regimen would become the first PARP-based precision medicine combination for this patient population, addressing a major unmet need among men with BRCA-mutated prostate cancer — a group known to experience faster disease progression and poorer outcomes than those without the mutation.

The submission is supported by data from the Phase 3 AMPLITUDE trial, which showed that Akeega plus prednisone reduced the risk of radiographic progression or death by 48% compared with abiraterone plus prednisone alone, according to J&J. The combination also prolonged time to symptomatic progression by 56% and showed a favorable trend toward overall survival improvement, with a 25% reduction in the risk of death, it adds

Akeega was approved in 2023 for BRCA-mutated metastatic castration-resistant prostate cancer.