{
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    "message": "Indication id ind:ema.itovebi:0 retrieved successfully",
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    "timestamp_received": "2026-04-24T16:08:43.712210+00:00Z",
    "timestamp_returned": "2026-04-24T16:08:43.719038+00:00Z",
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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"
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  "data": [
    {
      "id": "ind:ema.itovebi:0",
      "indication": "Itovebi, in combination with palbocicliab and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.",
      "initial_approval_date": "2025-08-27",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/assessment-report/itovebi-epar-public-assessment-report_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized inavolisib in combination with palbocicliab and fulvestrant for the treatment of adult patients with PIK3CA-mutated, estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.",
      "raw_biomarkers": "PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative",
      "raw_cancer_type": "breast cancer",
      "raw_therapeutics": "inavolisib in combination with palbocicliab 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:ema.itovebi",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Itovebi (inavolisib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Roche Registration GmbH. Itovebi (inavolisib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf.pdf. Revised August 2025. Accessed September 8, 2025.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi",
          "https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Roche Registration GmbH",
            "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."
          },
          {
            "name": "first_publication_date",
            "value": "2025-08-27",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-08-27",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}