{
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    "timestamp_received": "2026-04-23T22:08:21.930558+00:00Z",
    "timestamp_returned": "2026-04-23T22:08:21.934587+00:00Z",
    "trace_id": "5c4aabe2-eb2e-4669-96c4-d5e036c0db6e"
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.vanflyta:0",
      "indication": "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.",
      "initial_approval_date": "2023-07-20",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf",
      "description": "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.",
      "raw_biomarkers": "FLT3 internal tandem duplication (ITD)-positive",
      "raw_cancer_type": "newly diagnosed acute myeloid leukemia (AML)",
      "raw_therapeutics": "quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": "2023-07-20",
      "date_accelerated_approval": null,
      "document": {
        "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.",
        "urls": [
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          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216993"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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              "type": "Agent",
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              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
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                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
                },
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                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
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            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Daiichi Sankyo, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Vanflyta",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "quizartinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
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            "value": "2023-07-20",
            "description": "The publication date for the initial version of this document."
          },
          {
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            "value": 216993,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-06-25",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}