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    "name": "Molecular Oncology Almanac",
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    {
      "id": "ind:fda:kadcyla:0",
      "type": "Indication",
      "description": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.",
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          "date": "2024-10-30",
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          "type": "Contribution",
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          "id": "doc:fda:kadcyla",
          "type": "Document",
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          "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.",
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              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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              "value": "Kadcyla",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "value": "ado-trastuzumab emtansine",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          "id": "doc:fda:kadcyla:2013-02-22",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf. Revised February 2013. Accessed October 6, 2026.",
          "urls": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427"
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          "doi": null,
          "pmid": null,
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              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
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              "description": "The organization that published this document."
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              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "description": "The publication date for the document."
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          "description": "Current approval status."
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          "name": "statement description",
          "value": "The U.S. Food and Drug Administration granted approval to trastuzumab emtansine as a monotherapy for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy. The FDA product label states to select patients for therapy based on an FDA-approved companion diagnostic for Kadcyla.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}