{
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    "timestamp_received": "2026-11-09T16:14:14.095944Z",
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    "name": "Molecular Oncology Almanac",
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    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
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  "data": [
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      "id": "ind:ema:libtayo:1",
      "type": "Indication",
      "description": "LIBTAYO in combination with platinum_based chemotherapy is indicated for the first_line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.",
      "contributions": [
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          "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",
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            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:ema:2023-03-24:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2023-03-24",
          "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."
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      "reportedIn": [
        {
          "id": "doc:ema:libtayo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Libtayo (cemiplimab) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "Regeneron Ireland Designated Activity Company (DAC). Libtayo (cemiplimab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf. Revised January 2024. Accessed March 19, 2024.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo"
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          "doi": null,
          "pmid": null,
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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."
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            {
              "name": "company",
              "value": "Regeneron Ireland Designated Activity Company (DAC).",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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              "name": "drug_name_brand",
              "value": "Libtayo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
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              "name": "drug_name_generic",
              "value": "cemiplimab",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "value": "2019-07-05",
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              "value": "2024-01-12",
              "description": "The publication date for the document."
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              "value": null,
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            },
            {
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              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
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        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
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          "value": "The European Medicines Agency (EMA) has authorized cemiplimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumor cells), with no EGFR, ALK, or ROS1 aberrations. This indication is specifically for patients who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or patients with metastatic NSCLC. This indication is based on Study 16113, a randomized, multi-center, double-blind, active-controlled trial. The chemotherapy used in this study consisted of either carboplatin or cisplatin in combination with paclitaxel or pemetrexed.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}