{
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    "timestamp_received": "2026-04-23T21:24:22.372494+00:00Z",
    "timestamp_returned": "2026-04-23T21:24:22.376302+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.tevimbra:1",
      "indication": "Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score >= 5%.",
      "initial_approval_date": "2024-12-19",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/tevimbra-h-c-005919-ii-0003-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1 with a tumor area positivity (TAP) score >= 5%. This indication is based on BGB-A317-306, a multi-regional, randomized, placebo-controlled, double-blind phase 3 study. The chemotherapy doublet regimen consisted of: cisplatin and 5-FU; cisplatin and capecitabine; oxaliplatin and 5-FU; oxaliplatin and capecitabine; cisplatin and paclitaxel; or oxaliplatin and paclitaxel.",
      "raw_biomarkers": "PD-L1 with a TAP score >= 5%",
      "raw_cancer_type": "Oesophageal squamous cell carcinoma (OSCC)",
      "raw_therapeutics": "Tevimbra, in combination with platinum-based 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.tevimbra",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tevimbra (tislelizumab) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "BeiGene Ireland Ltd. Tevimbra (tislelizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf. Revised July 2025. Accessed September 5, 2025.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra",
          "https://www.ema.europa.eu/en/documents/product-information/tevimbra-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": "BeiGene Ireland Ltd.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tevimbra",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "tislelizumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2023-10-02",
            "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": "2025-07-14",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}