{
  "meta": {
    "data_length": 2,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=fda&proposition_id=356",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.068196,
    "timestamp_received": "2026-05-15T13:08:43.256745+00:00Z",
    "timestamp_returned": "2026-05-15T13:08:43.324941+00:00Z",
    "trace_id": "1fd80b4e-4906-4d9f-a529-c6fe9a28b5ae"
  },
  "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": 408,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel.",
      "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.perjeta",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Perjeta (pertuzumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Revised January 2020. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409"
          ],
          "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": "Genentech, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Perjeta",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "pertuzumab",
              "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": 125409,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2020-01-16",
              "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.perjeta:2",
        "indication": "PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.",
        "initial_approval_date": "2017-12-20",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf",
        "description": "The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel.",
        "raw_biomarkers": "HER2-positive",
        "raw_cancer_type": "early stage breast cancer",
        "raw_therapeutics": "Perjeta (pertuzumab) in combination with trastuzumab and chemotherapy",
        "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.perjeta",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Perjeta (pertuzumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Revised January 2020. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409"
          ],
          "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": "Genentech, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Perjeta",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "pertuzumab",
              "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": 125409,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2020-01-16",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      },
      "proposition": {
        "id": 356,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 20,
            "name": "HER2-positive",
            "genes": [],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Protein expression"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "marker",
                "value": "Human epidermal growth factor receptor 2 (HER2)"
              },
              {
                "name": "unit",
                "value": "status"
              },
              {
                "name": "equality",
                "value": "="
              },
              {
                "name": "value",
                "value": "Positive"
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 9,
          "conceptType": "Disease",
          "name": "Invasive Breast Carcinoma",
          "primaryCoding": {
            "id": "oncotree:BRCA",
            "code": "BRCA",
            "name": "Invasive Breast Carcinoma",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=BRCA"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 70,
          "membership_operator": "AND",
          "therapies": [
            {
              "id": 25,
              "conceptType": "Drug",
              "name": "Trastuzumab",
              "primaryCoding": {
                "id": "ncit:C1647",
                "code": "C1647",
                "name": "Trastuzumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1647"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:224905",
                    "code": "224905",
                    "name": "trastuzumab",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=224905"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4304158",
                    "code": "4304158",
                    "name": "Trastuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4304158"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387003001",
                    "code": "387003001",
                    "name": "Trastuzumab",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387003001&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1387104",
                    "code": "1387104",
                    "name": "trastuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1387104"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "HER2 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": 59,
              "conceptType": "Drug",
              "name": "Cyclophosphamide",
              "primaryCoding": {
                "id": "ncit:C405",
                "code": "C405",
                "name": "Cyclophosphamide",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C405"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:3002",
                    "code": "3002",
                    "name": "cyclophosphamide",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3002"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1310317",
                    "code": "1310317",
                    "name": "cyclophosphamide",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1310317"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387420009",
                    "code": "387420009",
                    "name": "Cyclophosphamide",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387420009&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4299054",
                    "code": "4299054",
                    "name": "Cyclophosphamide",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4299054"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Alkylating chemotherapy"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 2,
              "conceptType": "Drug",
              "name": "Doxorubicin",
              "primaryCoding": {
                "id": "ncit:C456",
                "code": "C456",
                "name": "Doxorubicin",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C456"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:3639",
                    "code": "3639",
                    "name": "doxorubicin",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3639"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4187583",
                    "code": "4187583",
                    "name": "Doxorubicin",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4187583"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:372817009",
                    "code": "372817009",
                    "name": "Doxorubicin",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=372817009&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1338512",
                    "code": "1338512",
                    "name": "doxorubicin",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1338512"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Topoisomerase inhibition"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 75,
              "conceptType": "Drug",
              "name": "Pertuzumab",
              "primaryCoding": {
                "id": "ncit:C38692",
                "code": "C38692",
                "name": "Pertuzumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38692"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:1298944",
                    "code": "1298944",
                    "name": "pertuzumab",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1298944"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:42801287",
                    "code": "42801287",
                    "name": "pertuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/42801287"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:704226002",
                    "code": "704226002",
                    "name": "Pertuzumab",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=704226002&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:45766952",
                    "code": "45766952",
                    "name": "Pertuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45766952"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "HER2 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": 29,
              "conceptType": "Drug",
              "name": "Fluorouracil",
              "primaryCoding": {
                "id": "ncit:C505",
                "code": "C505",
                "name": "Fluorouracil",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C505"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:4492",
                    "code": "4492",
                    "name": "fluorouracil",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=4492"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4300009",
                    "code": "4300009",
                    "name": "Fluorouracil",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4300009"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387172005",
                    "code": "387172005",
                    "name": "Fluorouracil",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387172005&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:955632",
                    "code": "955632",
                    "name": "fluorouracil",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/955632"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Thymidylate synthase inhibition"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 35,
              "conceptType": "Drug",
              "name": "Paclitaxel",
              "primaryCoding": {
                "id": "ncit:C1411",
                "code": "C1411",
                "name": "Paclitaxel",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:56946",
                    "code": "56946",
                    "name": "paclitaxel",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=56946"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4306859",
                    "code": "4306859",
                    "name": "Paclitaxel",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4306859"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387374002",
                    "code": "387374002",
                    "name": "Paclitaxel",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387374002&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1378382",
                    "code": "1378382",
                    "name": "paclitaxel",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1378382"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Taxane-based chemotherapy"
                  ],
                  "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"
                }
              ]
            }
          ]
        }
      }
    },
    {
      "id": 419,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.",
      "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.phesgo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Phesgo (pertuzumab and trastuzumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Revised June 2020. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761170"
          ],
          "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": "Genentech, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Phesgo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "pertuzumab and trastuzumab",
              "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": 761170,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2020-06-29",
              "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.phesgo:1",
        "indication": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.",
        "initial_approval_date": "2020-06-29",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf",
        "description": "The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.",
        "raw_biomarkers": "HER2-positive",
        "raw_cancer_type": "early breast cancer",
        "raw_therapeutics": "Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy",
        "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.phesgo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Phesgo (pertuzumab and trastuzumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Genentech, Inc. Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Revised June 2020. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761170"
          ],
          "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": "Genentech, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Phesgo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "pertuzumab and trastuzumab",
              "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": 761170,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2020-06-29",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      },
      "proposition": {
        "id": 356,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 20,
            "name": "HER2-positive",
            "genes": [],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Protein expression"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "marker",
                "value": "Human epidermal growth factor receptor 2 (HER2)"
              },
              {
                "name": "unit",
                "value": "status"
              },
              {
                "name": "equality",
                "value": "="
              },
              {
                "name": "value",
                "value": "Positive"
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 9,
          "conceptType": "Disease",
          "name": "Invasive Breast Carcinoma",
          "primaryCoding": {
            "id": "oncotree:BRCA",
            "code": "BRCA",
            "name": "Invasive Breast Carcinoma",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=BRCA"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 70,
          "membership_operator": "AND",
          "therapies": [
            {
              "id": 25,
              "conceptType": "Drug",
              "name": "Trastuzumab",
              "primaryCoding": {
                "id": "ncit:C1647",
                "code": "C1647",
                "name": "Trastuzumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1647"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:224905",
                    "code": "224905",
                    "name": "trastuzumab",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=224905"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4304158",
                    "code": "4304158",
                    "name": "Trastuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4304158"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387003001",
                    "code": "387003001",
                    "name": "Trastuzumab",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387003001&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1387104",
                    "code": "1387104",
                    "name": "trastuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1387104"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "HER2 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": 59,
              "conceptType": "Drug",
              "name": "Cyclophosphamide",
              "primaryCoding": {
                "id": "ncit:C405",
                "code": "C405",
                "name": "Cyclophosphamide",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C405"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:3002",
                    "code": "3002",
                    "name": "cyclophosphamide",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3002"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1310317",
                    "code": "1310317",
                    "name": "cyclophosphamide",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1310317"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387420009",
                    "code": "387420009",
                    "name": "Cyclophosphamide",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387420009&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4299054",
                    "code": "4299054",
                    "name": "Cyclophosphamide",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4299054"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Alkylating chemotherapy"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 2,
              "conceptType": "Drug",
              "name": "Doxorubicin",
              "primaryCoding": {
                "id": "ncit:C456",
                "code": "C456",
                "name": "Doxorubicin",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C456"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:3639",
                    "code": "3639",
                    "name": "doxorubicin",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3639"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4187583",
                    "code": "4187583",
                    "name": "Doxorubicin",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4187583"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:372817009",
                    "code": "372817009",
                    "name": "Doxorubicin",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=372817009&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1338512",
                    "code": "1338512",
                    "name": "doxorubicin",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1338512"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Topoisomerase inhibition"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 75,
              "conceptType": "Drug",
              "name": "Pertuzumab",
              "primaryCoding": {
                "id": "ncit:C38692",
                "code": "C38692",
                "name": "Pertuzumab",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38692"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:1298944",
                    "code": "1298944",
                    "name": "pertuzumab",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1298944"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:42801287",
                    "code": "42801287",
                    "name": "pertuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/42801287"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:704226002",
                    "code": "704226002",
                    "name": "Pertuzumab",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=704226002&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:45766952",
                    "code": "45766952",
                    "name": "Pertuzumab",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45766952"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "HER2 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": 29,
              "conceptType": "Drug",
              "name": "Fluorouracil",
              "primaryCoding": {
                "id": "ncit:C505",
                "code": "C505",
                "name": "Fluorouracil",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C505"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:4492",
                    "code": "4492",
                    "name": "fluorouracil",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=4492"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4300009",
                    "code": "4300009",
                    "name": "Fluorouracil",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4300009"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387172005",
                    "code": "387172005",
                    "name": "Fluorouracil",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387172005&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:955632",
                    "code": "955632",
                    "name": "fluorouracil",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/955632"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Thymidylate synthase inhibition"
                  ],
                  "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"
                }
              ]
            },
            {
              "id": 35,
              "conceptType": "Drug",
              "name": "Paclitaxel",
              "primaryCoding": {
                "id": "ncit:C1411",
                "code": "C1411",
                "name": "Paclitaxel",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411"
                ]
              },
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "rxcui:56946",
                    "code": "56946",
                    "name": "paclitaxel",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=56946"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:4306859",
                    "code": "4306859",
                    "name": "Paclitaxel",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4306859"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "sctid:387374002",
                    "code": "387374002",
                    "name": "Paclitaxel",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387374002&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "omop:1378382",
                    "code": "1378382",
                    "name": "paclitaxel",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1378382"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Taxane-based chemotherapy"
                  ],
                  "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"
                }
              ]
            }
          ]
        }
      }
    }
  ]
}