{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A341",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.006251,
    "timestamp_received": "2026-09-25T00:14:20.659108+00:00Z",
    "timestamp_returned": "2026-09-25T00:14:20.665359+00:00Z",
    "trace_id": "ada2f919-b10e-4c81-bd64-c5ef50d3e6b7"
  },
  "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": "2026-08-02"
  },
  "data": [
    {
      "id": "stmt:fda:keytruda:11:0",
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.",
      "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",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:keytruda",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Keytruda (pembrolizumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514"
          ],
          "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": "Merck Sharp & Dohme Corp.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Keytruda",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "pembrolizumab",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2014-09-04",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 125514,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2026-02-10",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "direction": "supports",
      "proposition": {
        "id": "prop:vtxr:341",
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictsSensitivityTo",
        "subjectVariant": {
          "type": "CategoricalVariant",
          "description": "Placeholder. Cat-VRS does not yet support sets of categorical variants. See the 'biomarkers' extension for biomarkers associated with this Proposition."
        },
        "conditionQualifier": {
          "id": "dis:oncotree:UCEC",
          "conceptType": "Disease",
          "name": "Endometrial Carcinoma",
          "mappings": [],
          "extensions": [
            {
              "name": "solid_tumor",
              "value": true,
              "description": "Boolean value for if this tumor type is categorized as a solid tumor."
            }
          ],
          "primaryCoding": {
            "id": "coding:oncotree:UCEC",
            "code": "UCEC",
            "name": "Endometrial Carcinoma",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=UCEC"
            ]
          }
        },
        "objectTherapeutic": {
          "id": "txgrp:61",
          "membershipOperator": "AND",
          "therapies": [
            {
              "id": "tx:ncit:C95124",
              "conceptType": "Therapy",
              "name": "Lenvatinib",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:1603296",
                    "code": "1603296",
                    "name": "lenvatinib",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1603296"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:46221433",
                    "code": "46221433",
                    "name": "lenvatinib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/46221433"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:714108002",
                    "code": "714108002",
                    "name": "Lenvatinib",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=714108002&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:37017773",
                    "code": "37017773",
                    "name": "Lenvatinib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/37017773"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "VEGFR inhibition"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Targeted therapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C95124",
                "code": "C95124",
                "name": "Lenvatinib",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C95124"
                ]
              }
            },
            {
              "id": "tx:ncit:C106432",
              "conceptType": "Therapy",
              "name": "Pembrolizumab",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:1547545",
                    "code": "1547545",
                    "name": "pembrolizumab",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1547545"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:45775965",
                    "code": "45775965",
                    "name": "pembrolizumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45775965"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:716125002",
                    "code": "716125002",
                    "name": "Pembrolizumab",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=716125002&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:37396350",
                    "code": "37396350",
                    "name": "Pembrolizumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/37396350"
                    ]
                  }
                }
              ],
              "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"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C106432",
                "code": "C106432",
                "name": "Pembrolizumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C106432"
                ]
              }
            }
          ]
        },
        "extensions": [
          {
            "name": "biomarkers",
            "value": [
              {
                "id": "bmkr.criterion:142",
                "present": true,
                "subject": {
                  "id": "bmkr:142",
                  "type": "CategoricalVariant",
                  "name": "MSI-L",
                  "constraints": [],
                  "extensions": [
                    {
                      "name": "biomarker_type",
                      "value": "Microsatellite stability"
                    },
                    {
                      "name": "status",
                      "value": "Microsatellite instability-low (MSI-L)"
                    }
                  ]
                }
              }
            ],
            "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). Multiple biomarkers are combined with implied AND logic."
          }
        ]
      },
      "strength": {
        "id": "str:ncit:C25425",
        "conceptType": "Evidence",
        "name": "Approval",
        "mappings": [],
        "primaryCoding": {
          "id": "coding:ncit:C25425",
          "code": "C25425",
          "name": "Approval",
          "system": "https://evsexplore.semantics.cancer.gov",
          "systemVersion": "25.01d",
          "iris": [
            "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25425"
          ]
        }
      },
      "extensions": [
        {
          "name": "status",
          "value": "Active",
          "description": "Whether this Statement is Active, Superseded, or Deprecated within moalmanac-db."
        },
        {
          "name": "indication",
          "value": {
            "id": "ind:fda:keytruda:11",
            "type": "Indication",
            "description": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.",
            "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",
                  "agentType": "contributor",
                  "name": "Van Allen lab",
                  "description": "Van Allen lab, Dana-Farber Cancer Institute"
                }
              }
            ],
            "reportedIn": [
              {
                "id": "doc:fda:keytruda",
                "type": "Document",
                "documentType": "Regulatory approval",
                "name": "Keytruda (pembrolizumab) [package insert]. FDA.",
                "title": null,
                "aliases": [],
                "description": "Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.",
                "urls": [
                  "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf",
                  "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514"
                ],
                "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": "Merck Sharp & Dohme Corp.",
                    "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_brand",
                    "value": "Keytruda",
                    "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_generic",
                    "value": "pembrolizumab",
                    "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "first_publication_date",
                    "value": "2014-09-04",
                    "description": "The publication date for the initial version of this document."
                  },
                  {
                    "name": "identification_number",
                    "value": 125514,
                    "description": "Identification number used by the publishing organization."
                  },
                  {
                    "name": "publication_date",
                    "value": "2026-02-10",
                    "description": "The publication date for the document."
                  },
                  {
                    "name": "status",
                    "value": "Active",
                    "description": "Whether this document is Active or Deprecated within moalmanac-db."
                  }
                ]
              }
            ],
            "extensions": [
              {
                "name": "status",
                "value": "Approved",
                "description": "Current approval status."
              }
            ]
          },
          "description": "The underlying Indication supporting this Statement."
        }
      ]
    }
  ]
}