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    {
      "id": "stmt:ema:kadcyla:1:0",
      "type": "Statement",
      "description": "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.",
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          "id": "ctrb:ema:2013-11-15:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2013-11-15",
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          "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.",
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              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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        "id": "prop:vtxr:20",
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictsSensitivityTo",
        "subjectVariant": {
          "type": "CategoricalVariant",
          "description": "Placeholder. Cat-VRS does not yet support sets of categorical variants. See the 'biomarkers' extension for biomarkers associated with this Proposition."
        },
        "conditionQualifier": {
          "id": "dis:ncit:C9245",
          "conceptType": "Disease",
          "name": "Invasive Breast Carcinoma",
          "mappings": [
            {
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              "coding": {
                "id": "coding:oncotree:BRCA",
                "code": "BRCA",
                "name": "Invasive Breast Carcinoma",
                "system": "https://oncotree.mskcc.org",
                "systemVersion": "oncotree_2025_10_03",
                "iris": [
                  "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Invasive+Breast+Carcinoma+%28BRCA%29"
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            }
          ],
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          }
        },
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          "id": "tx:ncit:C82492",
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          "name": "Trastuzumab emtansine",
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                "code": "1371041",
                "name": "ado-trastuzumab emtansine",
                "system": "RxNorm",
                "systemVersion": "02-Mar-2026",
                "iris": [
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            {
              "relation": "relatedMatch",
              "coding": {
                "id": "coding:omop:43525787",
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                "name": "ado-trastuzumab emtansine",
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                "systemVersion": "v20260227",
                "iris": [
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                ]
              }
            }
          ],
          "extensions": [
            {
              "name": "therapy_strategy",
              "value": [
                "HER2 inhibition"
              ],
              "description": "Associated therapeutic strategy or mechanism of action of the therapy."
            },
            {
              "name": "therapy_type",
              "value": "Targeted therapy",
              "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
            }
          ],
          "primaryCoding": {
            "id": "coding:ncit:C82492",
            "code": "C82492",
            "name": "Trastuzumab Emtansine",
            "system": "https://evsexplore.semantics.cancer.gov",
            "systemVersion": "26.08e",
            "iris": [
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            ]
          }
        },
        "extensions": [
          {
            "name": "biomarkers",
            "value": [
              {
                "id": "bmkr.criterion:20",
                "present": true,
                "subject": {
                  "id": "bmkr:20",
                  "type": "CategoricalVariant",
                  "name": "HER2-positive",
                  "constraints": [],
                  "extensions": [
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                      "name": "biomarker_type",
                      "value": "Protein expression"
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                      "name": "marker",
                      "value": "Human epidermal growth factor receptor 2 (HER2)"
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                    {
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                      "value": "status"
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                    {
                      "name": "equality",
                      "value": "="
                    },
                    {
                      "name": "value",
                      "value": "Positive"
                    }
                  ]
                }
              }
            ],
            "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). Multiple biomarkers are combined with implied AND logic."
          }
        ]
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        "conceptType": "Evidence",
        "name": "Approval",
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          "id": "coding:ncit:C25425",
          "code": "C25425",
          "name": "Approval",
          "system": "https://evsexplore.semantics.cancer.gov",
          "systemVersion": "26.08e",
          "iris": [
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      "extensions": [
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          "name": "status",
          "value": "Active",
          "description": "Whether this Statement is Active, Superseded, or Deprecated within moalmanac-db."
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          "name": "indication",
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            "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.",
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                "description": "Indication received approval from the European Commission.",
                "date": "2013-11-15",
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                  "id": "agent:org:ema",
                  "type": "Agent",
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                "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.",
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}