{ "meta": { "data_length": 2, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A20", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004318, "timestamp_received": "2026-09-25T00:14:25.091219+00:00Z", "timestamp_returned": "2026-09-25T00:14:25.095537+00:00Z", "trace_id": "51338941-c129-4f97-839b-3d49c8d6d255" }, "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:kadcyla:0:0", "type": "Statement", "description": "The U.S. Food and Drug Administration granted approval to trastuzumab emtansine as a monotherapy for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy. The FDA product label states to select patients for therapy based on an FDA-approved companion diagnostic for Kadcyla.", "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:2013-02-22:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2013-02-22", "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:kadcyla", "type": "Document", "documentType": "Regulatory approval", "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.", "title": null, "aliases": [], "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427" ], "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": "Genentech, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Kadcyla", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ado-trastuzumab emtansine", "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": 125427, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2022-02-02", "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:20", "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:BRCA", "conceptType": "Disease", "name": "Invasive Breast Carcinoma", "mappings": [], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:oncotree: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" ] } }, "objectTherapeutic": { "id": "tx:ncit:C82492", "conceptType": "Therapy", "name": "Trastuzumab emtansine", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:sctid:702836004", "code": "702836004", "name": "Trastuzumab emtansine", "system": "SNOMED", "systemVersion": "2025-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=702836004&edition=MAIN/2025-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:45765811", "code": "45765811", "name": "Trastuzumab emtansine", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/45765811" ] } } ], "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" } ], "primaryCoding": { "id": "coding:ncit:C82492", "code": "C82492", "name": "Trastuzumab Emtansine", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C82492" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:20", "present": true, "subject": { "id": "bmkr:20", "type": "CategoricalVariant", "name": "HER2-positive", "constraints": [], "extensions": [ { "name": "biomarker_type", "value": "Protein expression" }, { "name": "marker", "value": "Human epidermal growth factor receptor 2 (HER2)" }, { "name": "unit", "value": "status" }, { "name": "equality", "value": "=" }, { "name": "value", "value": "Positive" } ] } } ], "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:kadcyla:0", "type": "Indication", "description": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.", "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:2013-02-22:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2013-02-22", "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:kadcyla", "type": "Document", "documentType": "Regulatory approval", "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.", "title": null, "aliases": [], "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427" ], "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": "Genentech, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Kadcyla", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ado-trastuzumab emtansine", "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": 125427, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2022-02-02", "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." } ] }, { "id": "stmt:fda:kadcyla:1:0", "type": "Statement", "description": "The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine.", "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:2019-05-03:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2019-05-03", "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:kadcyla", "type": "Document", "documentType": "Regulatory approval", "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.", "title": null, "aliases": [], "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427" ], "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": "Genentech, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Kadcyla", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ado-trastuzumab emtansine", "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": 125427, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2022-02-02", "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:20", "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:BRCA", "conceptType": "Disease", "name": "Invasive Breast Carcinoma", "mappings": [], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:oncotree: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" ] } }, "objectTherapeutic": { "id": "tx:ncit:C82492", "conceptType": "Therapy", "name": "Trastuzumab emtansine", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:sctid:702836004", "code": "702836004", "name": "Trastuzumab emtansine", "system": "SNOMED", "systemVersion": "2025-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=702836004&edition=MAIN/2025-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:45765811", "code": "45765811", "name": "Trastuzumab emtansine", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/45765811" ] } } ], "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" } ], "primaryCoding": { "id": "coding:ncit:C82492", "code": "C82492", "name": "Trastuzumab Emtansine", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C82492" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:20", "present": true, "subject": { "id": "bmkr:20", "type": "CategoricalVariant", "name": "HER2-positive", "constraints": [], "extensions": [ { "name": "biomarker_type", "value": "Protein expression" }, { "name": "marker", "value": "Human epidermal growth factor receptor 2 (HER2)" }, { "name": "unit", "value": "status" }, { "name": "equality", "value": "=" }, { "name": "value", "value": "Positive" } ] } } ], "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:kadcyla:1", "type": "Indication", "description": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.", "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:2019-05-03:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2019-05-03", "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:kadcyla", "type": "Document", "documentType": "Regulatory approval", "name": "Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.", "title": null, "aliases": [], "description": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427" ], "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": "Genentech, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Kadcyla", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ado-trastuzumab emtansine", "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": 125427, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2022-02-02", "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." } ] } ] }