{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema.phesgo:1 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.phesgo%3A1",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004814,
    "timestamp_received": "2026-04-24T00:58:06.553632+00:00Z",
    "timestamp_returned": "2026-04-24T00:58:06.558446+00:00Z",
    "trace_id": "d7c9b018-4ef0-42da-bc8e-76aa412d37db"
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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.phesgo:1",
      "indication": "Phesgo is indicated for use in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.",
      "initial_approval_date": "2021-01-13",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/assessment-report/phesgo-epar-public-assessment-report_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, and placebo-cotrolled phase 3 trial conducted in 4804 patients with HER2-positive early breast cancer. Within this trial, investigators had the choice of one of the following chemotherapy regimens: 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxell; 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or 6 cycles of docetaxel in combination with carboplatin.",
      "raw_biomarkers": null,
      "raw_cancer_type": "Breast cancer",
      "raw_therapeutics": "Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy",
      "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.phesgo",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Phesgo (pertuzumab / trastuzumab) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Roche Registration GmbH. Phesgo (pertuzumab / trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf. Revised March 2022. Accessed March 22, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo",
          "https://www.ema.europa.eu/en/documents/product-information/phesgo-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": "Roche Registration GmbH.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Phesgo",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "pertuzumab / trastuzumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2021-01-13",
            "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": "2022-03-02",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}