{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:voranigo:0:18 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Avoranigo%3A0%3A18", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002088, "timestamp_received": "2026-10-16T22:58:47.502885+00:00Z", "timestamp_returned": "2026-10-16T22:58:47.504973+00:00Z", "trace_id": "6702dde7-96ed-4f2e-949a-cfee465f2164" }, "service": { "github": "https://github.com/vanallenlab/moalmanac-db", "name": "Molecular Oncology Almanac", "license": "GPL-2.0", "release": "draft", "url": "https://moalmanac.org", "last_updated": "2026-08-02" }, "data": [ { "id": "stmt:ema:voranigo:0:18", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized vorasidenib as a monotherapy for the treatment of adult and adolescent patients aged 12 years and older with predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation. 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EMA.", "title": null, "aliases": [], "description": "Les Laboratoires Servier. Voranigo (vorasidenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf. Revised September 2025. Accessed October 2, 2025.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/voranigo" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "agent:org:ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union." }, "description": "The organization that published this document." }, { "name": "company", "value": "Les Laboratoires Servier", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Voranigo", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "vorasidenib", "description": "The generic name of the cancer drug, per this document. 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"objectTherapeutic": { "id": "tx:ncit:C152914", "conceptType": "Therapy", "name": "Vorasidenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2690647", "code": "2690647", "name": "vorasidenib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2690647" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1735000", "code": "1735000", "name": "vorasidenib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1735000" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "IDH1/2 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:C152914", "code": "C152914", "name": "Vorasidenib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C152914" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:114", "present": true, "subject": { "id": "bmkr:114", "type": "CategoricalVariant", "name": "IDH2 p.R172S", "constraints": [ { "type": "DefiningAlleleConstraint", "allele": { "id": "ga4gh:VA.GcEWQeOqTVsh88PUGeuMNT2jNcjCzshC", "type": "Allele", "name": "NP_002159.2:p.Arg172Ser", "aliases": [ "NP_002159.2:p.R172S", "IDH2 p.R172S" ], "description": "VRS variation of NP_002159.2:p.Arg172Ser", "digest": "GcEWQeOqTVsh88PUGeuMNT2jNcjCzshC", "expressions": [ { "syntax": "hgvs.p", "value": "NP_002159.2:p.Arg172Ser", "extensions": [ { "name": "hgvs.p_short", "value": "p.R172S" } ] } ], "location": { "id": "ga4gh:SL.UuG3IrLVJV7S2Qjtt99SWVQuiYDLlHxa", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Amino acid position 172 of the Refseq protein NP_002159.2, which is the protein product of the MANE Select coding transcript for IDH2 (refseq:NM_002168.4).", "digest": "UuG3IrLVJV7S2Qjtt99SWVQuiYDLlHxa", "sequenceReference": { "id": "ga4gh:SQ.xop1Mrzn5Llu7Dj-BULoAd8Xmlbs-l-y", "type": "SequenceReference", "name": "NP_002159.2", "aliases": [ "ensembl:ENSP00000331897.3", "ga4gh:SQ.xop1Mrzn5Llu7Dj-BULoAd8Xmlbs-l-y", "refseq:NP_002159.2" ], "description": "The protein product of the MANE Select coding transcript for IDH2 (refseq:NM_002168.4), corresponding to the Refseq protein accession NP_002159.2.", "moleculeType": "protein", "refgetAccession": "SQ.xop1Mrzn5Llu7Dj-BULoAd8Xmlbs-l-y", "residueAlphabet": "aa" }, "start": 171, "end": 172, "sequence": "R" }, "state": { "type": "LiteralSequenceExpression", "sequence": "S" } }, "relations": [] }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:5383", "conceptType": "Gene", "name": "IDH2", "primaryCoding": { "id": "coding:hgnc:5383", "code": "HGNC:5383", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:5383" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000182054", "code": "ENSG00000182054", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000182054" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:3418", "code": "3418", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/3418" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_002168.4", "code": "NM_002168.4", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_002168.4" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Somatic variant" }, { "name": "chromosome", "value": "15" }, { "name": "start_position", "value": 90631837 }, { "name": "end_position", "value": 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EMA.", "title": null, "aliases": [], "description": "Les Laboratoires Servier. Voranigo (vorasidenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf. Revised September 2025. Accessed October 2, 2025.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/voranigo" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "agent:org:ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union." }, "description": "The organization that published this document." }, { "name": "company", "value": "Les Laboratoires Servier", "description": "The company that manufactures the cancer drug. 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