{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A191", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004644, "timestamp_received": "2026-09-25T00:14:16.828267+00:00Z", "timestamp_returned": "2026-09-25T00:14:16.832911+00:00Z", "trace_id": "a5f20b00-457a-49e1-8313-9365664ea68c" }, "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:tibsovo:3:1", "type": "Statement", "description": "The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated with a susceptible IDH1 mutation, as detected by an FDA-approved test. This indication is based on Study AG120-C-005 (NCT02989857), a randomized, multicenter, double-blind, placebo-controlled clinical trial consisting of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The product label notes that, across both arms of the trial, patients primarily had R132 variants: R132C (70% of patients), R132L (15%), R132G (12%), R132H (1.1%), and R132S (1.6%).", "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:2021-08-25:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2021-08-25", "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:tibsovo", "type": "Document", "documentType": "Regulatory approval", "name": "Tibsovo (ivosidenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211192" ], "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": "Agios Pharmaceuticals, Inc.", "description": "The company that manufactures the cancer drug. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:oncotree:CHOL", "conceptType": "Disease", "name": "Cholangiocarcinoma", "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:CHOL", "code": "CHOL", "name": "Cholangiocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=CHOL" ] } }, "objectTherapeutic": { "id": "tx:ncit:C114383", "conceptType": "Therapy", "name": "Ivosidenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2049873", "code": "2049873", "name": "ivosidenib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2049873" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1560123", "code": "1560123", "name": "ivosidenib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1560123" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:773232006", "code": "773232006", "name": "Ivosidenib", "system": "SNOMED", "systemVersion": "2025-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=773232006&edition=MAIN/2025-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:36676369", "code": "36676369", "name": "Ivosidenib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/36676369" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "IDH1 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Targeted therapy", 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