{
  "meta": {
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    "message": "Indication id ind:fda.modeyso:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.modeyso%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003724,
    "timestamp_received": "2026-04-24T17:03:50.552402+00:00Z",
    "timestamp_returned": "2026-04-24T17:03:50.556126+00:00Z",
    "trace_id": "7c9ef936-9532-4034-b0f7-032861edc050"
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  "service": {
    "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.modeyso:0",
      "indication": "MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.",
      "initial_approval_date": "2025-08-06",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on 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. H3 K27M The underlying trials, including ONC018 (NCT03134131), assessed H3 K27M status through either IHC or sequencing for patient eligibility. The H3 K27M nomenclature refers to the H3-3A:c.83A>T p.K28M (K27M) variant.",
      "raw_biomarkers": "H3 K27M",
      "raw_cancer_type": "diffuse midline glioma",
      "raw_therapeutics": "Modeyso (dordaviprone)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2025-08-06",
      "document": {
        "id": "doc:fda.modeyso",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Modeyso (dordaviprone) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Chimerix, Inc. Modeyso (dordaviprone) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf. Revised August 2025. Accessed October 2, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219876"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "fda",
              "type": "Agent",
              "agentType": "organization",
              "name": "Food and Drug Administration",
              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Chimerix, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Modeyso",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "dordaviprone",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2025-08-06",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 219876,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-08-06",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}