{
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    "timestamp_elapsed": 0.003723,
    "timestamp_received": "2026-04-24T00:59:43.597672+00:00Z",
    "timestamp_returned": "2026-04-24T00:59:43.601395+00:00Z",
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    "name": "Molecular Oncology Almanac",
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    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:ema.truqap:0",
      "indication": "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.",
      "initial_approval_date": "2024-07-11",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/assessment-report/truqap-epar-public-assessment-report_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized capivasertib in combination with fulvestrant for the treatment of adult patients with estrogen 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. Capivasertib's product information further states that in pre- or perimenopausal women, capivasertib plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. The product information further states that, for men, administration of LHRH agonist according to current clinical practices should be considered. This indication is based on CAPItello-291, a randomized, double-blind, placebo-controlled trial, where HER2-negative status was defined as either IHC 0 or 1+, or IHC 2+/ISH-, and qualifying alterations were activating mutations in PIK3CA and AKT1 and inactivating mutations in PTEN.",
      "raw_biomarkers": null,
      "raw_cancer_type": "locally advanced or metastatic breast cancer",
      "raw_therapeutics": "Truqap (capivasertib) in combination with fulvestrant",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:ema.truqap",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Truqap (capivasertib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "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.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/truqap",
          "https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "AstraZeneca AB.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Truqap",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "capivasertib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2024-07-11",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-07-11",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}