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    2. doc:ema:akeega

    Akeega (abiraterone acetate and niraparib) [product information]. EMA.

    Regulatory approval published by the European Medicines Agency.

    Citation

    Janssen-Cilag International N.V. Akeega (abiraterone acetate and niraparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.

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    Regulatory approvals

    Approved indications from this document for cancer drugs containing at least one biomarker.

    Indication Statements
    Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
    Akeega is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline or somatic).

    Therapeutic response

    Precision oncology relationships for therapeutic response derived from this document.

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