{
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    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.verzenios%3A0",
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    "status_code": 200,
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    "timestamp_received": "2026-04-24T02:29:26.031156+00:00Z",
    "timestamp_returned": "2026-04-24T02:29:26.035014+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"
  },
  "data": [
    {
      "id": "ind:ema.verzenios:0",
      "indication": "Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.",
      "initial_approval_date": "2022-04-21",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/verzenios-h-c-004302-ii-0013-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. Abemaciclib's product information further states that in pre- or perimenopausal women, aromatase inhibitor endrocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. The product information further states that this indication was approved based on results from the monarchE study, a randomized, open label, two cohort, phase 3 study which enrolled a total of 5,637 patients who were randomized in a 1:1 ratio to receive 2 years of abemaciclib plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).",
      "raw_biomarkers": null,
      "raw_cancer_type": "Breast cancer",
      "raw_therapeutics": "Verzenios (abemaciclib) in combination with endocrine therapy",
      "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.verzenios",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Verzenios (abemaciclib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Eli Lilly Nederland B.V. Verzenios (abemaciclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf. Revised March 2024. Accessed March 25, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios",
          "https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "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": "Eli Lilly Nederland B.V.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Verzenios",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "abemaciclib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2018-10-29",
            "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": "2024-03-12",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}