{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema:itovebi:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema%3Aitovebi%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.00164,
    "timestamp_received": "2026-09-25T06:04:10.076914+00:00Z",
    "timestamp_returned": "2026-09-25T06:04:10.078554+00:00Z",
    "trace_id": "269690d6-89b4-4f40-824f-03c9232dae67"
  },
  "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": "2026-08-02"
  },
  "data": [
    {
      "id": "ind:ema:itovebi:0",
      "type": "Indication",
      "description": "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.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-09-08:3",
          "type": "Contribution",
          "description": "On 2025-08-27, the EMA approved Itovebi (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.",
          "date": "2025-09-08",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:ema:2025-07-18:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2025-07-18",
          "contributor": {
            "id": "agent:org:ema",
            "type": "Agent",
            "agentType": "organization",
            "name": "European Medicines Agency",
            "description": "Regulatory agency that approves medicines for use in the European Union."
          }
        }
      ],
      "reportedIn": [
        {
          "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/documents/product-information/itovebi-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "agent",
              "value": {
                "id": "agent:org:ema",
                "type": "Agent",
                "agentType": "organization",
                "name": "European Medicines Agency",
                "description": "Regulatory agency that approves medicines for use in the European Union."
              },
              "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."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        }
      ]
    }
  ]
}