{
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    "timestamp_received": "2026-11-09T16:11:41.180173Z",
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  "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:fda:opdivo:4",
      "type": "Indication",
      "description": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-04-30:0",
          "type": "Contribution",
          "description": "The FDA provided regular approval to nivolumab in combination with ipilimumab the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. However, they split the approval in two indications: as a single agent and still as a combination for patients who have progressed on the previously listed therapies. We added a new indication to cover the combination treatment and updated all statements and propositions accordingly.",
          "date": "2025-04-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2025-04-08:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2025-04-08",
          "contributor": {
            "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."
          }
        },
        {
          "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",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2018-07-10:0",
          "type": "Contribution",
          "description": "Indication received accelerated approval.",
          "date": "2018-07-10",
          "contributor": {
            "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."
          }
        }
      ],
      "reportedIn": [
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          "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"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "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."
            },
            {
              "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."
            },
            {
              "name": "first_publication_date",
              "value": "2014-12-22",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2025-04-11",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "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)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        },
        {
          "id": "doc:fda:opdivo:2018-07-10",
          "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/2018/125554s063lbl.pdf. Revised July 2018. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.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."
            },
            {
              "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."
            },
            {
              "name": "first_publication_date",
              "value": "2014-12-22",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2018-07-10",
              "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)."
            },
            {
              "name": "status",
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              "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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          "name": "statement description",
          "value": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}