{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A244",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004103,
    "timestamp_received": "2026-09-25T01:17:17.045350+00:00Z",
    "timestamp_returned": "2026-09-25T01:17:17.049453+00:00Z",
    "trace_id": "581250e4-980f-4264-a693-07db8210aeeb"
  },
  "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:lynparza:1:1",
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.",
      "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"
          }
        },
        {
          "id": "ctrb:fda:2020-05-08:1",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2020-05-08",
          "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."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:lynparza",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Lynparza (olaparib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208558"
          ],
          "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": "AstraZeneca Pharmaceuticals, LP.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Lynparza",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "olaparib",
              "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": 208558,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2023-11-06",
              "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:244",
        "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:OVT",
          "conceptType": "Disease",
          "name": "Ovarian Epithelial Tumor",
          "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:OVT",
            "code": "OVT",
            "name": "Ovarian Epithelial Tumor",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=OVT"
            ]
          }
        },
        "objectTherapeutic": {
          "id": "txgrp:43",
          "membershipOperator": "AND",
          "therapies": [
            {
              "id": "tx:ncit:C2039",
              "conceptType": "Therapy",
              "name": "Bevacizumab",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:253337",
                    "code": "253337",
                    "name": "bevacizumab",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=253337"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4247981",
                    "code": "4247981",
                    "name": "Bevacizumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4247981"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:409406007",
                    "code": "409406007",
                    "name": "Bevacizumab",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=409406007&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1397141",
                    "code": "1397141",
                    "name": "bevacizumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1397141"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "VEGF 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:C2039",
                "code": "C2039",
                "name": "Bevacizumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2039"
                ]
              }
            },
            {
              "id": "tx:ncit:C71721",
              "conceptType": "Therapy",
              "name": "Olaparib",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:1597582",
                    "code": "1597582",
                    "name": "olaparib",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1597582"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:45892579",
                    "code": "45892579",
                    "name": "olaparib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45892579"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:432162002",
                    "code": "432162002",
                    "name": "Olaparib",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=432162002&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4332351",
                    "code": "4332351",
                    "name": "Olaparib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4332351"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "PARP 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:C71721",
                "code": "C71721",
                "name": "Olaparib",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C71721"
                ]
              }
            }
          ]
        },
        "extensions": [
          {
            "name": "biomarkers",
            "value": [
              {
                "id": "bmkr.criterion:48",
                "present": true,
                "subject": {
                  "id": "bmkr:48",
                  "type": "CategoricalVariant",
                  "name": "BRCA1 pathogenic variants",
                  "constraints": [
                    {
                      "type": "DefiningLocationConstraint",
                      "location": {
                        "id": "ga4gh:SL.weCy_6qoSvyzu7QVSpaJMaGWcDUKmqXb",
                        "type": "SequenceLocation",
                        "name": null,
                        "aliases": [],
                        "description": "Sequence spanning the length of refseq:NP_009225.1, the protein product of the MANE Select coding transcript for BRCA1 (refseq:NM_007294.4).",
                        "digest": "weCy_6qoSvyzu7QVSpaJMaGWcDUKmqXb",
                        "sequenceReference": {
                          "id": "ga4gh:SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y",
                          "type": "SequenceReference",
                          "name": "NP_009225.1",
                          "aliases": [
                            "ensembl:ENSP00000350283.3",
                            "ga4gh:SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y",
                            "refseq:NP_009225.1"
                          ],
                          "description": "The protein product of the MANE Select coding transcript for BRCA1 (refseq:NM_007294.4), corresponding to the Refseq protein accession NP_009225.1.",
                          "moleculeType": "protein",
                          "refgetAccession": "SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y",
                          "residueAlphabet": "aa"
                        },
                        "start": 0,
                        "end": 1863,
                        "sequence": null
                      },
                      "relations": [],
                      "matchCharacteristic": {
                        "primaryCoding": {
                          "code": "is_within",
                          "system": "ga4gh-gks-term:location-match"
                        }
                      }
                    },
                    {
                      "type": "FeatureContextConstraint",
                      "featureContext": {
                        "id": "gene:hgnc:1100",
                        "conceptType": "Gene",
                        "name": "BRCA1",
                        "primaryCoding": {
                          "id": "coding:hgnc:1100",
                          "code": "HGNC:1100",
                          "system": "https://genenames.org",
                          "iris": [
                            "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1100"
                          ]
                        },
                        "mappings": [
                          {
                            "relation": "exactMatch",
                            "coding": {
                              "id": "coding:ensembl:ensg00000012048",
                              "code": "ENSG00000012048",
                              "system": "https://www.ensembl.org",
                              "iris": [
                                "https://www.ensembl.org/id/ENSG00000012048"
                              ]
                            }
                          },
                          {
                            "relation": "exactMatch",
                            "coding": {
                              "id": "coding:ncbi:672",
                              "code": "672",
                              "system": "https://www.ncbi.nlm.nih.gov/gene",
                              "iris": [
                                "https://www.ncbi.nlm.nih.gov/gene/672"
                              ]
                            }
                          },
                          {
                            "relation": "relatedMatch",
                            "coding": {
                              "id": "coding:refseq:NM_007294.4",
                              "code": "NM_007294.4",
                              "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                              "iris": [
                                "https://www.ncbi.nlm.nih.gov/nuccore/NM_007294.4"
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ],
                  "extensions": [
                    {
                      "name": "biomarker_type",
                      "value": "Germline variant"
                    },
                    {
                      "name": "chromosome",
                      "value": "17"
                    },
                    {
                      "name": "start_position",
                      "value": null
                    },
                    {
                      "name": "end_position",
                      "value": null
                    },
                    {
                      "name": "reference_allele",
                      "value": null
                    },
                    {
                      "name": "alternate_allele",
                      "value": null
                    },
                    {
                      "name": "cdna_change",
                      "value": null
                    },
                    {
                      "name": "protein_change",
                      "value": null
                    },
                    {
                      "name": "variant_annotation",
                      "value": null
                    },
                    {
                      "name": "exon",
                      "value": null
                    },
                    {
                      "name": "rsid",
                      "value": null
                    },
                    {
                      "name": "hgvsg",
                      "value": null
                    },
                    {
                      "name": "hgvsc",
                      "value": null
                    },
                    {
                      "name": "requires_pathogenic",
                      "value": true
                    }
                  ]
                }
              }
            ],
            "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:lynparza:1",
            "type": "Indication",
            "description": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.",
            "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"
                }
              },
              {
                "id": "ctrb:fda:2020-05-08:1",
                "type": "Contribution",
                "description": "Indication received traditional approval.",
                "date": "2020-05-08",
                "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."
                }
              }
            ],
            "reportedIn": [
              {
                "id": "doc:fda:lynparza",
                "type": "Document",
                "documentType": "Regulatory approval",
                "name": "Lynparza (olaparib) [package insert]. FDA.",
                "title": null,
                "aliases": [],
                "description": "AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.",
                "urls": [
                  "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf",
                  "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208558"
                ],
                "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": "AstraZeneca Pharmaceuticals, LP.",
                    "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_brand",
                    "value": "Lynparza",
                    "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_generic",
                    "value": "olaparib",
                    "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": 208558,
                    "description": "Identification number used by the publishing organization."
                  },
                  {
                    "name": "publication_date",
                    "value": "2023-11-06",
                    "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."
        }
      ]
    }
  ]
}