{
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    "timestamp_received": "2026-04-26T11:14:17.875417+00:00Z",
    "timestamp_returned": "2026-04-26T11:14:17.879495+00:00Z",
    "trace_id": "37dac64b-db49-4075-ab2c-9b16a7112bce"
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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"
  },
  "data": [
    {
      "id": "ind:fda.pemazyre:0",
      "indication": "PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "initial_approval_date": "2020-04-17",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to pemigatinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "FGFR2 fusion or other rearrangement",
      "raw_cancer_type": "unresectable locally advanced or metastatic cholangiocarcinoma",
      "raw_therapeutics": "Pemazyre (pemigatinib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:fda.pemazyre",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Pemazyre (pemigatinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf. Revised August 2022. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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              "type": "Agent",
              "agentType": "organization",
              "name": "Food and Drug Administration",
              "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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                {
                  "name": "url",
                  "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": "Incyte Corporation.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Pemazyre",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "pemigatinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
            "name": "first_publication_date",
            "value": null,
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 213736,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2020-04-17",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}