{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.scemblix:1 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.scemblix%3A1",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003841,
    "timestamp_received": "2026-04-24T18:59:17.193165+00:00Z",
    "timestamp_returned": "2026-04-24T18:59:17.197006+00:00Z",
    "trace_id": "0752129e-1c2f-4e56-aaac-0630e2e68243"
  },
  "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.scemblix:1",
      "indication": "SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.",
      "initial_approval_date": "2021-10-29",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation.",
      "raw_biomarkers": "philadelphia chromosome-positive with the T315I mutation",
      "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)",
      "raw_therapeutics": "Scemblix (asciminib)",
      "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.scemblix",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Scemblix (asciminib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed January 10, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215358"
        ],
        "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": "Novartis Pharmaceuticals Corporation.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Scemblix",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "asciminib",
            "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": "identification_number",
            "value": 215358,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-10-29",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}