{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?proposition_id=509&agent_id=fda&agent_id=ema",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.018202,
    "timestamp_received": "2026-04-12T05:45:57.035069+00:00Z",
    "timestamp_returned": "2026-04-12T05:45:57.053271+00:00Z",
    "trace_id": "69ec3d5c-5a03-4f55-9619-19162f0e503a"
  },
  "service": {
    "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"
  },
  "data": [
    {
      "id": 593,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.",
      "contributions": [
        {
          "id": 4,
          "type": "Contribution",
          "agent": {
            "id": "vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute",
            "last_updated": null,
            "url": null
          },
          "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"
        },
        {
          "id": 0,
          "type": "Contribution",
          "agent": {
            "id": "vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute",
            "last_updated": null,
            "url": null
          },
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30"
        }
      ],
      "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"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States.",
                "extensions": [
                  {
                    "name": "last_updated",
                    "value": "2026-04-09",
                    "description": ""
                  },
                  {
                    "name": "url",
                    "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                    "description": ""
                  }
                ]
              },
              "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": "identification_number",
              "value": 125554,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2025-04-11",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "direction": "supports",
      "indication": {
        "id": "ind:fda.opdivo:3",
        "indication": "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 microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.",
        "initial_approval_date": "2018-07-10",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf",
        "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.",
        "raw_biomarkers": "microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)",
        "raw_cancer_type": "colorectal cancer",
        "raw_therapeutics": "nivolumab as a single agent",
        "icd10": null,
        "regimen_code": null,
        "reimbursement_category": null,
        "reimbursement_date": null,
        "reimbursement_details": null,
        "date_regular_approval": "2024-04-08",
        "date_accelerated_approval": "2018-07-10",
        "document": {
          "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": [
            {
              "name": "agent",
              "value": {
                "id": "fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States.",
                "extensions": [
                  {
                    "name": "last_updated",
                    "value": "2026-04-09",
                    "description": ""
                  },
                  {
                    "name": "url",
                    "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                    "description": ""
                  }
                ]
              },
              "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": "identification_number",
              "value": 125554,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2025-04-11",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      },
      "proposition": {
        "id": 509,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 36,
            "name": "dMMR",
            "genes": [],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Mismatch Repair"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "status",
                "value": "Deficient"
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 15,
          "conceptType": "Disease",
          "name": "Colorectal Adenocarcinoma",
          "primaryCoding": {
            "id": "oncotree:COADREAD",
            "code": "COADREAD",
            "name": "Colorectal Adenocarcinoma",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=COADREAD"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 72,
          "conceptType": "Drug",
          "name": "Nivolumab",
          "primaryCoding": {
            "id": "ncit:C68814",
            "code": "C68814",
            "name": "Nivolumab",
            "system": "https://evsexplore.semantics.cancer.gov",
            "systemVersion": "25.01d",
            "iris": [
              "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68814"
            ]
          },
          "mappings": [],
          "extensions": [
            {
              "name": "therapy_strategy",
              "value": [
                "PD-1/PD-L1 inhibition"
              ],
              "description": "Associated therapeutic strategy or mechanism of action of the therapy."
            },
            {
              "name": "therapy_type",
              "value": "Immunotherapy",
              "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
            }
          ]
        }
      }
    }
  ]
}