{
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    "timestamp_elapsed": 0.001693,
    "timestamp_received": "2026-11-09T16:12:24.211641Z",
    "timestamp_returned": "2026-11-09T16:12:24.213334Z",
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "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:fda:komzifti:0",
      "type": "Indication",
      "description": "KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alterantive treatment options.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-12-23:1",
          "type": "Contribution",
          "description": "On 2025-11-13, the US FDA granted regular approval to ziftomenib for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with susceptible NPM1 mutation who have no satisfactory alternative treatment options.",
          "date": "2025-12-23",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2025-11-13:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2025-11-13",
          "contributor": {
            "id": "agent:org:fda",
            "type": "Agent",
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            "name": "Food and Drug Administration",
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          }
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          "id": "doc:fda:komzifti",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Komzifti (ziftomenib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Kura Oncology, Inc. Komzifti (ziftomenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf. Revised November 2025. Accessed December 23, 2025.",
          "urls": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305"
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          "pmid": null,
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              "description": "The organization that published this document."
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            {
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              "value": "Kura Oncology, Inc",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Komzifti",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "ziftomenib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "value": "2025-11-13",
              "description": "The publication date for the initial version of this document."
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          "id": "doc:fda:komzifti:2025-11-13",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Komzifti (ziftomenib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Kura Oncology, Inc. Komzifti (ziftomenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf. Revised November 2025. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
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                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "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 initial version of this document."
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              "value": "2025-11-13",
              "description": "The publication date for the document."
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              "name": "status",
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      "extensions": [
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          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
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        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration (FDA) granted approval to ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. This approval is based on NCT04067336, an open-label, single-arm, multicenter clinical trial of 112 patients where eligibility criteria included NPM1 mutations, including Type A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG) mutations and other NPM1 mutations likely to result in cytoplasmic localization of the NPM1 protein.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}