{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=fda&proposition_id=295",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.030157,
    "timestamp_received": "2026-05-15T13:11:56.779620+00:00Z",
    "timestamp_returned": "2026-05-15T13:11:56.809777+00:00Z",
    "trace_id": "55774581-be23-44ec-ac19-c9954859b43e"
  },
  "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": 341,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.",
      "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.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": "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": "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",
      "indication": {
        "id": "ind:fda.lynparza:7",
        "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.",
        "initial_approval_date": "2023-05-31",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf",
        "description": "The U.S. Food and Drug Administration granted approval to olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.",
        "raw_biomarkers": "deleterious or suspected deleterious BRCA-mutated",
        "raw_cancer_type": "metastatic castration-resistant prostate cancer",
        "raw_therapeutics": "Lynparza (olaparib) in combination with abiraterone and prednisolone or prednisone",
        "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.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": "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": "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."
            }
          ]
        }
      },
      "proposition": {
        "id": 295,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 47,
            "name": "BRCA1 oncogenic variants",
            "genes": [
              {
                "id": 9,
                "name": "BRCA1",
                "primaryCoding": {
                  "id": "hgnc:1100",
                  "code": "HGNC:1100",
                  "name": null,
                  "system": "https://genenames.org",
                  "systemVersion": null,
                  "iris": [
                    "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1100"
                  ]
                },
                "mappings": [
                  {
                    "relation": "relatedMatch",
                    "coding": {
                      "id": "refseq:NM_007294.4",
                      "code": "NM_007294.4",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/nuccore/NM_007294.4"
                      ]
                    }
                  },
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ensembl:ensg00000012048",
                      "code": "ENSG00000012048",
                      "name": null,
                      "system": "https://www.ensembl.org",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ensembl.org/id/ENSG00000012048"
                      ]
                    }
                  },
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ncbi:672",
                      "code": "672",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/gene",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/gene/672"
                      ]
                    }
                  }
                ],
                "extensions": [
                  {
                    "name": "location",
                    "value": "17q21.31"
                  },
                  {
                    "name": "location_sortable",
                    "value": "17q21.31"
                  }
                ]
              }
            ],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Somatic Variant"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "chromosome",
                "value": "17"
              },
              {
                "name": "requires_oncogenic",
                "value": true
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 55,
          "conceptType": "Disease",
          "name": "Prostate Adenocarcinoma",
          "primaryCoding": {
            "id": "oncotree:PRAD",
            "code": "PRAD",
            "name": "Prostate Adenocarcinoma",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=PRAD"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 46,
          "membership_operator": "AND",
          "therapies": [
            {
              "id": 46,
              "conceptType": "Drug",
              "name": "Olaparib",
              "primaryCoding": {
                "id": "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"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "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": "omop:45892579",
                    "code": "45892579",
                    "name": "olaparib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45892579"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "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": "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"
                }
              ]
            },
            {
              "id": 7,
              "conceptType": "Drug",
              "name": "Abiraterone acetate",
              "primaryCoding": {
                "id": "ncit:C68845",
                "code": "C68845",
                "name": "Abiraterone Acetate",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68845"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:1100071",
                    "code": "1100071",
                    "name": "abiraterone acetate",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1100071"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:44783577",
                    "code": "44783577",
                    "name": "Abiraterone acetate",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/44783577"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:699679004",
                    "code": "699679004",
                    "name": "Abiraterone acetate",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=699679004&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:46274231",
                    "code": "46274231",
                    "name": "abiraterone acetate",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/46274231"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Antiandrogen"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Hormone therapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ]
            },
            {
              "id": 122,
              "conceptType": "Drug",
              "name": "Prednisone",
              "primaryCoding": {
                "id": "ncit:C770",
                "code": "C770",
                "name": "Prednisone",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C770"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:8640",
                    "code": "8640",
                    "name": "prednisone",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=8640"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1551099",
                    "code": "1551099",
                    "name": "prednisone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1551099"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:116602009",
                    "code": "116602009",
                    "name": "Prednisone",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=116602009&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4023242",
                    "code": "4023242",
                    "name": "Prednisone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4023242"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Corticosteroid"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ]
            }
          ]
        }
      }
    }
  ]
}