{
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    "timestamp_received": "2026-11-09T16:11:42.819956Z",
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    "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"
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  "data": [
    {
      "id": "ind:fda:opdivo:0",
      "type": "Indication",
      "description": "OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "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:fda:2024-10-03:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2024-10-03",
          "contributor": {
            "id": "agent:org:fda",
            "type": "Agent",
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            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
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      "reportedIn": [
        {
          "id": "doc:fda:opdivo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Opdivo (nivolumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554"
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          "pmid": null,
          "extensions": [
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                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Bristol-Myers Squibb Company.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Opdivo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "nivolumab",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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            {
              "name": "first_publication_date",
              "value": "2014-12-22",
              "description": "The publication date for the initial version of this document."
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            {
              "name": "publication_date",
              "value": "2025-04-11",
              "description": "The publication date for the document."
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              "value": "BLA125554",
              "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)."
            },
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        },
        {
          "id": "doc:fda:opdivo:2024-10-03",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Opdivo (nivolumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf. Revised October 2024. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
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              "value": "Bristol-Myers Squibb Company.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Opdivo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "nivolumab",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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            {
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              "value": "2014-12-22",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2024-10-03",
              "description": "The publication date for the document."
            },
            {
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              "value": "BLA125554",
              "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)."
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              "value": "Deprecated",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
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        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration granted approval to nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment after surgery, of adult patients with resectable (tumors >= 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements. This indication is based on CHECKMATE-816 (NCT02998528), a randomized, open label trial where patients received either: carboplatin with paclitaxel for either histology, cisplatin with pemetrexed for non-squamous histology, or cisplatin with gemcitabine for squamous histology.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}