EMA Filing for Akeega in HRR-Mutant mHSPC Based on AMPLITUDE Data

On July 3, 2025, Janssen submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for Akeega (niraparib + abiraterone) in HRR-mutated metastatic hormone-sensitive prostate cancer (mHSPC). The submission is based on AMPLITUDE trial data showing significant rPFS improvements. If approved, Akeega would be the first PARP-based combo available for HRR-altered mHSPC in Europe.

‍Citation: https://innovativemedicine.jnj.com/us/news-center/oncology/johnson-johnson-submits-application-to-the-european-medicines-agency-seeking-indication-extension-of-akeega-niraparib-and-abiraterone-acetate-dual-action-tablet-for-the-treatment-of-adult-patients-with-metastatic-hormone-sensitive-prostate-cancer-and-hrr-gene-alterations

‍Implication: EMA expansion suggests strategic push into first-line mHSPC; early engagement with European payers and prescriber education on HRR testing is essential.