{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A519", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004125, "timestamp_received": "2026-09-25T00:13:56.102323+00:00Z", "timestamp_returned": "2026-09-25T00:13:56.106448+00:00Z", "trace_id": "75e60d1d-8844-4389-9415-68e432f904ff" }, "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:bizengri:1:0", "type": "Statement", "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", "contributions": [ { "id": "ctrb:vanallenlab:2025-01-10:0", "type": "Contribution", "description": "Additional FDA approvals for initial version", "date": "2025-01-10", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2024-12-04:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2024-12-04", "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:bizengri", "type": "Document", "documentType": "Regulatory approval", "name": "Bizengri (zenocutuzumab-zbco) [package insert]. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:oncotree:PAAD", "conceptType": "Disease", "name": "Pancreatic Adenocarcinoma", "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:PAAD", "code": "PAAD", "name": "Pancreatic Adenocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=PAAD" ] } }, "objectTherapeutic": { "id": "tx:ncit:C152948", "conceptType": "Therapy", "name": "Zenocutuzumab", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2699588", "code": "2699588", "name": "zenocutuzumab", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2699588" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1464913", "code": "1464913", "name": "zenocutuzumab", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1464913" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "NRG1 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:C152948", "code": "C152948", "name": "Zenocutuzumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C152948" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:156", "present": true, "subject": { "id": "bmkr:156", "type": "CategoricalVariant", "name": "v::NRG1", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": false, "adjoinedElements": [ { "id": "gene:hgnc:7997", "conceptType": "Gene", "name": "NRG1", "primaryCoding": { "id": "coding:hgnc:7997", "code": "HGNC:7997", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:7997" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000157168", "code": "ENSG00000157168", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000157168" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:3084", "code": "3084", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/3084" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_013964.5", "code": "NM_013964.5", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_013964.5" ] } } ] }, { "type": "UnspecifiedElement" } ] } ], "extensions": [ { "name": "biomarker_type", "value": "Gene fusion" } ] } } ], "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). 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