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    2. doc:ema:truqap

    Truqap (capivasertib) [product information]. EMA.

    Regulatory approval published by the European Medicines Agency.

    Citation

    AstraZeneca AB. Truqap (capivasertib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf. Revised July 2024. Accessed October 18, 2024.

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    Regulatory approvals

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

    Indication Statements
    TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practices should be considered.

    Therapeutic response

    Precision oncology relationships for therapeutic response derived from this document.

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