{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:sprycel:3:0 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Asprycel%3A3%3A0", "status": "success", "status_code": 200, "timestamp_elapsed": 0.001941, "timestamp_received": "2026-10-16T23:26:36.689859+00:00Z", "timestamp_returned": "2026-10-16T23:26:36.691800+00:00Z", "trace_id": "33a24bbf-93ad-4ddf-86a8-9a43991ebdc0" }, "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:sprycel:3:0", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized dasatinib (anhydrous) for the treatment of pediatric patients with newly diagnosed Philadelphia acute lymphoblastic leukemia (ALL) in combination with chemotherapy. The product information for this indication further states that his indication is based on a multicenter, historically-controlled phase 2 study that followed the chemotherapy regime detailed in another clinical trial, AIEOP-BFM ALL 2000 (chemotherapeutic standard multi-agent chemotherapy protocol).", "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:2019-02-06:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2019-02-06", "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:sprycel", "type": "Document", "documentType": "Regulatory approval", "name": "Sprycel (dasatinib [anhydrous]) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Sprycel (dasatinib [anhydrous]) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf. Revised June 2022. Accessed March 22, 2024.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel" ], "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": "Bristol-Myers Squibb Pharma EEIG.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Sprycel", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "dasatinib", "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:C3167", "conceptType": "Disease", "name": "Acute Lymphoblastic Leukemia", "mappings": [ { "relation": "narrowMatch", "coding": { "id": "coding:oncotree:BLL", "code": "BLL", "name": "B-Lymphoblastic Leukemia/Lymphoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=B-Lymphoblastic+Leukemia%2FLymphoma+%28BLL%29" ] } }, { "relation": "narrowMatch", "coding": { "id": "coding:oncotree:TLL", "code": "TLL", "name": "T-Lymphoblastic Leukemia/Lymphoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=T-Lymphoblastic+Leukemia%2FLymphoma+%28TLL%29" ] } } ], "extensions": [ { "name": "solid_tumor", "value": false, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:ncit:C3167", "code": "C3167", "name": "Acute Lymphoblastic Leukemia", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C3167" ] } }, "objectTherapeutic": { "id": "tx:ncit:C38713", "conceptType": "Therapy", "name": "Dasatinib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:475342", "code": "475342", "name": "dasatinib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=475342" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1358436", "code": "1358436", "name": "dasatinib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1358436" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "BCR-ABL 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:C38713", "code": "C38713", "name": "Dasatinib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38713" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:15", "present": false, "subject": { "id": "bmkr:12", "type": "CategoricalVariant", "name": "BCR::ABL1", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": true, "adjoinedElements": [ { "id": "gene:hgnc:1014", "conceptType": "Gene", "name": "BCR", "primaryCoding": { "id": "coding:hgnc:1014", "code": "HGNC:1014", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1014" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000186716", "code": "ENSG00000186716", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000186716" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:613", "code": "613", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/613" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_004327.4", "code": "NM_004327.4", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004327.4" ] } } ] }, { "id": "gene:hgnc:76", "conceptType": "Gene", "name": "ABL1", "primaryCoding": { "id": "coding:hgnc:76", "code": "HGNC:76", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:76" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000097007", "code": "ENSG00000097007", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000097007" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:25", "code": "25", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/25" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_005157.6", "code": "NM_005157.6", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005157.6" ] } } ] } ] } ], "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": "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:sprycel:3", "type": "Indication", "description": "SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.", "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:2019-02-06:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2019-02-06", "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:sprycel", "type": "Document", "documentType": "Regulatory approval", "name": "Sprycel (dasatinib [anhydrous]) [product information]. 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