{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=fda&proposition_id=87",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.022246,
    "timestamp_received": "2026-05-15T13:04:22.481999+00:00Z",
    "timestamp_returned": "2026-05-15T13:04:22.504245+00:00Z",
    "trace_id": "b089d011-cd88-4d5a-8755-a68c15b453d5"
  },
  "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": "2026-05-07"
  },
  "data": [
    {
      "id": 93,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.",
      "contributions": [
        {
          "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.xalkori",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Xalkori (crizotinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf. Revised September 2023. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202570"
          ],
          "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": "2026-05-07",
                    "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": "Pfizer, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Xalkori",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "crizotinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": null,
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 202570,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2023-09-07",
              "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.xalkori:2",
        "indication": "XALKORI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.",
        "initial_approval_date": "2022-07-14",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf",
        "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.",
        "raw_biomarkers": "ALK-positive",
        "raw_cancer_type": "unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT)",
        "raw_therapeutics": "Xalkori (crizotinib)",
        "icd10": null,
        "regimen_code": null,
        "reimbursement_category": null,
        "reimbursement_date": null,
        "reimbursement_details": null,
        "date_regular_approval": null,
        "date_accelerated_approval": null,
        "document": {
          "id": "doc:fda.xalkori",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Xalkori (crizotinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf. Revised September 2023. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202570"
          ],
          "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": "2026-05-07",
                    "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": "Pfizer, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Xalkori",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "crizotinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": null,
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 202570,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2023-09-07",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      },
      "proposition": {
        "id": 87,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 8,
            "name": "v::ALK",
            "genes": [
              {
                "id": 2,
                "name": "ALK",
                "primaryCoding": {
                  "id": "hgnc:427",
                  "code": "HGNC:427",
                  "name": null,
                  "system": "https://genenames.org",
                  "systemVersion": null,
                  "iris": [
                    "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:427"
                  ]
                },
                "mappings": [
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ensembl:ensg00000171094",
                      "code": "ENSG00000171094",
                      "name": null,
                      "system": "https://www.ensembl.org",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ensembl.org/id/ENSG00000171094"
                      ]
                    }
                  },
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ncbi:238",
                      "code": "238",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/gene",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/gene/238"
                      ]
                    }
                  },
                  {
                    "relation": "relatedMatch",
                    "coding": {
                      "id": "refseq:NM_004304.5",
                      "code": "NM_004304.5",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/nuccore/NM_004304.5"
                      ]
                    }
                  }
                ],
                "extensions": [
                  {
                    "name": "location",
                    "value": "2p23.2-p23.1"
                  },
                  {
                    "name": "location_sortable",
                    "value": "02p23.2-p23.1"
                  }
                ]
              }
            ],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Rearrangement"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "rearrangement_type",
                "value": "Fusion"
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 28,
          "conceptType": "Disease",
          "name": "Inflammatory Myofibroblastic Tumor",
          "primaryCoding": {
            "id": "oncotree:IMT",
            "code": "IMT",
            "name": "Inflammatory Myofibroblastic Tumor",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=IMT"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 102,
          "conceptType": "Drug",
          "name": "Crizotinib",
          "primaryCoding": {
            "id": "ncit:C74061",
            "code": "C74061",
            "name": "Crizotinib",
            "system": "https://evsexplore.semantics.cancer.gov",
            "systemVersion": "25.01d",
            "iris": [
              "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74061"
            ]
          },
          "mappings": [
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "rxcui:1148495",
                "code": "1148495",
                "name": "crizotinib",
                "system": "RxNorm",
                "systemVersion": "02-Mar-2026",
                "iris": [
                  "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1148495"
                ]
              }
            },
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "omop:40242675",
                "code": "40242675",
                "name": "crizotinib",
                "system": "OMOP",
                "systemVersion": "v20260227",
                "iris": [
                  "https://athena.ohdsi.org/search-terms/terms/40242675"
                ]
              }
            },
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "sctid:703637000",
                "code": "703637000",
                "name": "Crizotinib",
                "system": "SNOMED",
                "systemVersion": "2025-03-01",
                "iris": [
                  "https://browser.ihtsdotools.org/?perspective=full&conceptId1=703637000&edition=MAIN/2025-03-01&release=&languages=en"
                ]
              }
            },
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "omop:45766472",
                "code": "45766472",
                "name": "Crizotinib",
                "system": "OMOP",
                "systemVersion": "v20260227",
                "iris": [
                  "https://athena.ohdsi.org/search-terms/terms/45766472"
                ]
              }
            }
          ],
          "extensions": [
            {
              "name": "therapy_strategy",
              "value": [
                "ALK inhibition",
                "MET inhibition",
                "ROS1 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"
            }
          ]
        }
      }
    }
  ]
}