{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A471", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004124, "timestamp_received": "2026-09-25T00:14:00.260322+00:00Z", "timestamp_returned": "2026-09-25T00:14:00.264446+00:00Z", "trace_id": "6e513dd6-35e8-4757-a66d-e90f99471def" }, "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:ojemda:0:1", "type": "Statement", "description": "The U.S. Food and Drug Administration granted accelerated approval to tovorafenib for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The product label states that this indication is approved under accelerated approval based on response rate and duration of response and furthermore 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: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:2024-04-23:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2024-04-23", "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:ojemda", "type": "Document", "documentType": "Regulatory approval", "name": "Ojemda (tovorafenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217700" ], "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": "Day One Biopharmaceuticals, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Ojemda", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "tovorafenib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2024-04-23", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 217700, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2024-04-23", "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:471", "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:LGGNOS", "conceptType": "Disease", "name": "Low-Grade Glioma, NOS", "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:LGGNOS", "code": "LGGNOS", "name": "Low-Grade Glioma, NOS", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=LGGNOS" ] } }, "objectTherapeutic": { "id": "tx:ncit:C106254", "conceptType": "Therapy", "name": "Tovorafenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2682434", "code": "2682434", "name": "tovorafenib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2682434" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1734345", "code": "1734345", "name": "tovorafenib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1734345" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "B-RAF 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:C106254", "code": "C106254", "name": "Tovorafenib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C106254" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:154", "present": true, "subject": { "id": "bmkr:154", "type": "CategoricalVariant", "name": "v::BRAF", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": false, "adjoinedElements": [ { "id": "gene:hgnc:1097", "conceptType": "Gene", "name": "BRAF", "primaryCoding": { "id": "coding:hgnc:1097", "code": "HGNC:1097", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1097" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000157764", "code": "ENSG00000157764", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000157764" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:673", "code": "673", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/673" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_004333.6", "code": "NM_004333.6", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004333.6" ] } } ] }, { "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). 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:ojemda:0", "type": "Indication", "description": "OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.", "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:2024-04-23:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2024-04-23", "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:ojemda", "type": "Document", "documentType": "Regulatory approval", "name": "Ojemda (tovorafenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217700" ], "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": "Day One Biopharmaceuticals, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Ojemda", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "tovorafenib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2024-04-23", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 217700, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2024-04-23", "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": "Accelerated", "description": "Current approval status." } ] }, "description": "The underlying Indication supporting this Statement." } ] } ] }