{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema:tevimbra:0 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Aema%3Atevimbra%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001558,
    "timestamp_received": "2026-11-09T16:14:18.100074Z",
    "timestamp_returned": "2026-11-09T16:14:18.101632Z",
    "trace_id": "8e6d097e-0be9-401f-8294-c2c03b50c70d"
  },
  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
  },
  "data": [
    {
      "id": "ind:ema:tevimbra:0",
      "type": "Indication",
      "description": "Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on >= 50% of tumor cells with no EGFR or ALK positive mutations and who have (i) locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or (ii) metastatic NSCLC.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-20:0",
          "type": "Contribution",
          "description": "Adding EMA approvals for use to database",
          "date": "2024-10-20",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:ema:2024-07-08:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2024-07-08",
          "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: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/documents/product-information/tevimbra-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "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": "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": "publication_date",
              "value": "2025-07-14",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": null,
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The European Medicines Agency (EMA) has authorized tislelizumab in combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression >= 50% of tumor cells with no EGFR or ALK positive mutations and who have either (i) locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or (ii) metastatic NSCLC. This indication is based on BGB-A317-304, a randomized, open-label, and multicenter phase 3 study where patients were randomized (2:1) to receive tislelizumab in combination with pemetrexed and carboplatin or cisplatin (n=223) or pemetrexed and carboplatin or cisplatin (n=111), where the choice of platinum (cisplatin or carboplatin) was the investigator's choice. Tislelizumab's product information further states that the study excluded patients with active brain or leptomeningeal metastases, known EGFR mutations or ALK translocations sensitive to available targeted inhibitor therapy, active autoimmune disease, or any condition requiring systemic treatment with either corticosteroids or other immunosuppressants.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}