{
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    "timestamp_received": "2026-11-09T16:12:15.015236Z",
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    "name": "Molecular Oncology Almanac",
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    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
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  "data": [
    {
      "id": "ind:fda:balversa:0",
      "type": "Indication",
      "description": "BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2024-01-19:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2024-01-19",
          "contributor": {
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            "type": "Agent",
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            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
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      "reportedIn": [
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          "id": "doc:fda:balversa",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Balversa (erdafitinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Janssen Products, LP. Balversa (erdafitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf. Revised January 2024. Accessed October 30, 2024.",
          "urls": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212018"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "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."
            },
            {
              "name": "company",
              "value": "Janssen Products, LP.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Balversa",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
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              "value": "erdafitinib",
              "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": null,
              "description": "The publication date for the initial version of this document."
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            {
              "name": "publication_date",
              "value": "2024-01-19",
              "description": "The publication date for the document."
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              "value": "NDA212018",
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              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
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          ]
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          "id": "doc:fda:balversa:2024-01-19",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Balversa (erdafitinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Janssen Products, LP. Balversa (erdafitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf. Revised January 2024. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212018"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "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."
              },
              "description": "The organization that published this document."
            },
            {
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              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
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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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              "value": "erdafitinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": null,
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2024-01-19",
              "description": "The publication date for the document."
            },
            {
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              "value": "NDA212018",
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Deprecated",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
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          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration granted approval to erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib's product label states for patients to be selected for therapy based on an FDA-approved companion diagnostic for erdafitinib. Furthermore, erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}