{
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    "message": "Indication id ind:fda.itovebi:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.itovebi%3A0",
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    "timestamp_received": "2026-04-06T16:11:13.456241+00:00Z",
    "timestamp_returned": "2026-04-06T16:11:13.459893+00:00Z",
    "trace_id": "949ec327-8155-4e35-8fd7-498a2f77b293"
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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": "2026-03-05"
  },
  "data": [
    {
      "id": "ind:fda.itovebi:0",
      "indication": "ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.",
      "initial_approval_date": "2024-10-10",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted approval to inavolisib in combination with palbociclib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.",
      "raw_biomarkers": "PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative",
      "raw_cancer_type": "metastatic breast cancer",
      "raw_therapeutics": "inavolisib in combination with palbociclib and fulvestrant",
      "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.itovebi",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Itovebi (inavolisib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Genentech, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf. Revised October 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219249"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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              "type": "Agent",
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              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
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                  "value": "2026-03-02",
                  "description": ""
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                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
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              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Genentech, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Itovebi",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "inavolisib",
            "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": "2024-10-10",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 219249,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-10-10",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}