{
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    "timestamp_received": "2026-11-09T16:13:10.343345Z",
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    "name": "Molecular Oncology Almanac",
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    "last_updated": "2026-10-08"
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  "data": [
    {
      "id": "ind:fda:vanflyta:0",
      "type": "Indication",
      "description": "VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-10-03:1",
          "type": "Contribution",
          "description": "On 2023-07-20 the FDA granted granted approval to quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as a maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.",
          "date": "2025-10-03",
          "contributor": {
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            "type": "Agent",
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            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
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        {
          "id": "ctrb:fda:2023-07-20:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2023-07-20",
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          "id": "doc:fda:vanflyta",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Vanflyta (quizartinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Daiichi Sankyo, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216993s001lbl.pdf. Revised June 2024. Accessed October 3, 2025.",
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              "description": "The organization that published this document."
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              "value": "Vanflyta",
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          "id": "doc:fda:vanflyta:2023-07-20",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Vanflyta (quizartinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Daiichi Sankyo, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf. Revised July 2023. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216993"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "agent",
              "value": {
                "id": "agent:org:fda",
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                "description": "Regulatory agency that approves drugs for use in the United States."
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              "value": "2023-07-20",
              "description": "The publication date for the document."
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      "extensions": [
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          "name": "status",
          "value": "Approved",
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          "value": "The U.S. Food and Drug Administration (FDA) granted approval to quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as a maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. This indication is based on QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled trial of 539 patients where patients received cytarabine with either daunorubicin or idarubicin.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}