{
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    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Aema%3Akadcyla%3A1",
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    "timestamp_received": "2026-11-09T16:17:49.212659Z",
    "timestamp_returned": "2026-11-09T16:17:49.214227Z",
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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
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  "data": [
    {
      "id": "ind:ema:kadcyla:1",
      "type": "Indication",
      "description": "Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-20:0",
          "type": "Contribution",
          "description": "Adding EMA approvals for use to database",
          "date": "2024-10-20",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:ema:2013-11-15:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2013-11-15",
          "contributor": {
            "id": "agent:org:ema",
            "type": "Agent",
            "agentType": "organization",
            "name": "European Medicines Agency",
            "description": "Regulatory agency that approves medicines for use in the European Union."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:ema:kadcyla",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Kadcyla (trastuzumab emtansine) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "Roche Registration GmbH. Kadcyla (trastuzumab emtansine) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf. Revised March 2023. Accessed March 19, 2024.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/kadcyla"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:ema",
                "type": "Agent",
                "agentType": "organization",
                "name": "European Medicines Agency",
                "description": "Regulatory agency that approves medicines for use in the European Union."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Roche Registration GmbH.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Kadcyla",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "trastuzumab emtansine",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2013-12-19",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2023-03-22",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": null,
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The European Medicines Agency (EMA) has authorized trastuzumab emtansine for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in cobmination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. The product information further specifies that patients treated with trastuzumab emtansine should have HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}