J&J Seeks EMA Nod to Expand Akeega Use in Prostate Cancer Cases

Janssen-Cilag International NV, which is a Johnson & Johnson subsidiary, submitted an extension of indication application to the European Medicines Agency (EMA) for the approval of AKEEGA (niraparib and abiraterone acetate), in combination with prednisone or prednisolone, for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair (HRR) gene alterations.

mHSPC is a more mature prostate cancer stage that goes outside the prostate gland but remains hormone-sensitive. Even with the newer treatments, almost all mHSPC will ultimately become metastatic castration-resistant prostate cancer (mCRPC), a virulent and incurable state of disease. HRR gene mutations, such as BRCA1/2 mutations, occur in over 20% of mHSPC patients, who have a worse prognosis and fewer treatment choices.

The extension is backed by safety data demonstrating consistency with the existing experience in mCRPC for which the niraparib-abiraterone combination is already indicated. The combination has been noted to transform the treatment of prostate cancer by providing a targeted solution to patients having an HRR gene alteration.

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“At Johnson & Johnson, we’re committed to meeting the individual needs of patients by advancing personalized and effective therapies across all stages of prostate cancer,” said Dr. Charles Drake, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson Innovative Medicine.

The EMA filing is supported by AMPLITUDE trial data, which were presented in a late-breaking oral session at the 2025 American Society of Clinical Oncology Annual Meeting. The trial was voted Best of ASCO and was part of the ASCO Press Programme, which indicates the clinical relevance of the results.