{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:zelboraf:0:1 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Azelboraf%3A0%3A1", "status": "success", "status_code": 200, "timestamp_elapsed": 0.001955, "timestamp_received": "2026-10-16T23:31:56.954492+00:00Z", "timestamp_returned": "2026-10-16T23:31:56.956447+00:00Z", "trace_id": "956f7a83-133e-40a9-be7f-1d5051c72ad5" }, "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:zelboraf:0:1", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Vemurafenib's product information states the special warning and caution that the efficacy and safety of vemurafenib in patients with tumors expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established.", "contributions": [ { "id": "ctrb:vanallenlab:2024-10-20:0", "type": "Contribution", "description": "Adding EMA approvals for use to database", "date": "2024-10-20", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2012-02-17:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2012-02-17", "contributor": { "id": "agent:org:ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union." } } ], "reportedIn": [ { "id": "doc:ema:zelboraf", "type": "Document", "documentType": "Regulatory approval", "name": "Zelboraf (vemurafenib) [product information]. EMA.", "title": null, "aliases": [], "description": "Roche Registration GmbH. Zelboraf (vemurafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf. Revised July 2023. Accessed March 26, 2024.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf" ], "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": "Roche Registration GmbH.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Zelboraf", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "vemurafenib", "description": "The generic name of the cancer drug, per this document. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:ncit:C3224", "conceptType": "Disease", "name": "Melanoma", "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:oncotree:MEL", "code": "MEL", "name": "Melanoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Melanoma+%28MEL%29" ] } } ], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:ncit:C3224", "code": "C3224", "name": "Melanoma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C3224" ] } }, "objectTherapeutic": { "id": "tx:ncit:C64768", "conceptType": "Therapy", "name": "Vemurafenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:1147220", "code": "1147220", "name": "vemurafenib", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1147220" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:40241937", "code": "40241937", "name": "vemurafenib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/40241937" ] } } ], "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:C64768", "code": "C64768", "name": "Vemurafenib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64768" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:17", "present": true, "subject": { "id": "bmkr:17", "type": "CategoricalVariant", "name": "BRAF p.V600K", "constraints": [ { "type": "DefiningAlleleConstraint", "allele": { "id": "ga4gh:VA.pfWn9x9oFBRzGda1xXcOrE-BrX0R__N8", "type": "Allele", "name": "NP_004324.2:p.Val600Lys", "aliases": [ "NP_004324.2:p.V600K", "BRAF p.V600K" ], "description": "VRS variation of NP_004324.2:p.Val600Lys", "digest": "pfWn9x9oFBRzGda1xXcOrE-BrX0R__N8", "expressions": [ { "syntax": "hgvs.p", "value": "NP_004324.2:p.Val600Lys", "extensions": [ { "name": "hgvs.p_short", "value": "p.V600K" } ] } ], "location": { "id": "ga4gh:SL.t-3DrWALhgLdXHsupI-e-M00aL3HgK3y", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Amino acid position 600 of the Refseq protein NP_004324.2, which is the protein product of the MANE Select coding transcript for BRAF (refseq:NM_004333.6).", "digest": "t-3DrWALhgLdXHsupI-e-M00aL3HgK3y", "sequenceReference": { "id": "ga4gh:SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "type": "SequenceReference", "name": "NP_004324.2", "aliases": [ "ensembl:ENSP00000288602.6", "ga4gh:SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "refseq:NP_004324.2" ], "description": "The protein product of the MANE Select coding transcript for BRAF (refseq:NM_004333.6), corresponding to the Refseq protein accession NP_004324.2.", "moleculeType": "protein", "refgetAccession": "SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "residueAlphabet": "aa" }, "start": 599, "end": 600, "sequence": "V" }, "state": { "type": "LiteralSequenceExpression", "sequence": "K" } }, "relations": [] }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:1097", "conceptType": "Gene", "name": "BRAF", "primaryCoding": { "id": "coding:hgnc:1097", "code": "HGNC:1097", "system": "https://genenames.org", "iris": [ 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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": "26.08e", "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:ema:zelboraf:0", "type": "Indication", "description": "Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation- positive unresectable or metastatic melanoma.", "contributions": [ { "id": "ctrb:vanallenlab:2024-10-20:0", "type": "Contribution", "description": "Adding EMA approvals for use to database", "date": "2024-10-20", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2012-02-17:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2012-02-17", "contributor": { "id": "agent:org:ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union." } } ], "reportedIn": [ { "id": "doc:ema:zelboraf", "type": "Document", "documentType": "Regulatory approval", "name": "Zelboraf (vemurafenib) [product information]. 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