{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:balversa:0:5 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Abalversa%3A0%3A5", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002196, "timestamp_received": "2026-10-16T23:32:15.695169+00:00Z", "timestamp_returned": "2026-10-16T23:32:15.697365+00:00Z", "trace_id": "4e54b899-17b3-44f7-9363-8f25ff474ee9" }, "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:balversa:0:5", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized erdafitinib for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting. This indication is based on BLC3001 Study Cohort 1, a Phase 3, randomised, open-label, multicentre study, where eligible patients were required to have at least one of the following FGFR fusions: FGFR2::BICC1, FGFR2::CASP7, FGFR3::TACC3, FGFR3::BAIAP2L1; or 1 of the following FGFR3 gene mutations: R248C, S249C, G370C, Y373C.", "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:2024-08-22:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2024-08-22", "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:balversa", "type": "Document", "documentType": "Regulatory approval", "name": "Balversa (erdafitinib) [product information]. EMA.", "title": null, "aliases": [], "description": "Janssen-Cilag International N.V. Balversa (erdafitinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf. Revised August 2024. Accessed October 19, 2024.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/balversa" ], "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": "Janssen-Cilag International N.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Balversa", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "erdafitinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2024-08-29", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2024-08-29", "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:127", "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:ncit:C39851", "conceptType": "Disease", "name": "Bladder Urothelial Carcinoma", "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:oncotree:BLCA", "code": "BLCA", "name": "Bladder Urothelial Carcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Bladder+Urothelial+Carcinoma+%28BLCA%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:C39851", "code": "C39851", "name": "Bladder Urothelial Carcinoma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39851" ] } }, "objectTherapeutic": { "id": "tx:ncit:C103273", "conceptType": "Therapy", "name": "Erdafitinib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2123125", "code": "2123125", "name": "erdafitinib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2123125" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1511250", "code": "1511250", "name": "erdafitinib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1511250" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "FGFR 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:C103273", "code": "C103273", "name": "Erdafitinib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103273" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:102", "present": true, "subject": { "id": "bmkr:102", "type": "CategoricalVariant", "name": "FGFR3 p.Y373C", "constraints": [ { "type": "DefiningAlleleConstraint", "allele": { "id": "ga4gh:VA.UHA6S3oE8Ts_WI51w5noSpXhSlvNEjHu", "type": "Allele", "name": "NP_000133.1:p.Tyr373Cys", "aliases": [ "NP_000133.1:p.Y373C", "FGFR3 p.Y373C" ], "description": "VRS variation of NP_000133.1:p.Tyr373Cys", "digest": "UHA6S3oE8Ts_WI51w5noSpXhSlvNEjHu", "expressions": [ { "syntax": "hgvs.p", "value": "NP_000133.1:p.Tyr373Cys", "extensions": [ { "name": "hgvs.p_short", "value": "p.Y373C" } ] } ], "location": { "id": "ga4gh:SL.g33H1Cf5jJONJO2upu64mfFipyfSK6MZ", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Amino acid position 373 of the Refseq protein NP_000133.1, which is the protein product of the MANE Select coding transcript for FGFR3 (refseq:NM_000142.5).", "digest": "g33H1Cf5jJONJO2upu64mfFipyfSK6MZ", "sequenceReference": { "id": "ga4gh:SQ.xO86teDIIalLkqprCQaXyuvdPqvBxBG3", "type": "SequenceReference", "name": "NP_000133.1", "aliases": [ "ensembl:ENSP00000260795.2", "ga4gh:SQ.xO86teDIIalLkqprCQaXyuvdPqvBxBG3", "refseq:NP_000133.1" ], "description": "The protein product of the MANE Select coding transcript for FGFR3 (refseq:NM_000142.5), corresponding to the Refseq protein accession NP_000133.1.", "moleculeType": "protein", "refgetAccession": "SQ.xO86teDIIalLkqprCQaXyuvdPqvBxBG3", "residueAlphabet": "aa" }, "start": 372, "end": 373, "sequence": "Y" }, "state": { "type": "LiteralSequenceExpression", "sequence": "C" } }, "relations": [] }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:3690", "conceptType": "Gene", "name": "FGFR3", "primaryCoding": { "id": "coding:hgnc:3690", "code": "HGNC:3690", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3690" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000068078", "code": "ENSG00000068078", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000068078" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:2261", "code": "2261", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/2261" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_000142.5", "code": "NM_000142.5", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_000142.5" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Somatic variant" }, { "name": "chromosome", "value": "4" }, { "name": "start_position", "value": 1806099 }, { "name": "end_position", "value": 1806099 }, { "name": "reference_allele", "value": "A" }, { "name": "alternate_allele", "value": "G" }, { "name": "cdna_change", "value": "c.1118A>G" }, { "name": "protein_change", "value": "p.Y373C" }, { "name": "variant_annotation", "value": "Missense" }, { "name": "exon", "value": 8 }, { "name": "rsid", "value": "rs121913485" }, { "name": "hgvsg", "value": "4:g.1806099A>G" }, { "name": "hgvsc", "value": "ENST00000260795.2:c.1118A>G" } ] } } ], "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:balversa:0", "type": "Indication", "description": "Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.", "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:2024-08-22:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2024-08-22", "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:balversa", "type": "Document", "documentType": "Regulatory approval", "name": "Balversa (erdafitinib) [product information]. EMA.", "title": null, "aliases": [], "description": "Janssen-Cilag International N.V. Balversa (erdafitinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf. Revised August 2024. Accessed October 19, 2024.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/balversa" ], "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": "Janssen-Cilag International N.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Balversa", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "erdafitinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2024-08-29", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2024-08-29", "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": "Approved", "description": "Current approval status." } ] }, "description": "The underlying Indication supporting this Statement." } ] } ] }