{ "meta": { "data_length": 1, "message": "Statement id stmt:hc:balversa:0:1 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Ahc%3Abalversa%3A0%3A1", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002106, "timestamp_received": "2026-10-16T23:59:37.447952+00:00Z", "timestamp_returned": "2026-10-16T23:59:37.450058+00:00Z", "trace_id": "b8739c9a-888b-41a6-8e2e-6b7dc9e0caf0" }, "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:hc:balversa:0:1", "type": "Statement", "description": "Health Canada approved erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC) harboring susceptible FGFR3 genetic alterations, who have experienced disease progression during or after at least one line of prior therapy, including within 12 months of neoadjuvant or adjuvant therapy.", "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" } } ], "reportedIn": [ { "id": "doc:hc:balversa", "type": "Document", "documentType": "Regulatory approval", "name": "Balversa (erdafitinib) [product monograph]. HC.", "title": null, "aliases": [], "description": "Janssen Inc. Balversa (erdafitinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082880.PDF. Revised December 2025. Accessed April 2026.", "urls": [ "https://pdf.hres.ca/dpd_pm/00082880.PDF", "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98320" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "agent:org:hc", "type": "Agent", "agentType": "organization", "name": "Health Canada", "description": "Regulatory agency that approves drugs for sale and use in Canada." }, "description": "The organization that published this document." }, { "name": "company", "value": "Janssen Inc.", "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. 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Cat-VRS does not yet support sets of categorical variants. 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position 249 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": "grxGJfSaMBBsfK5DECZSAECGGUC1gixU", "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": 248, "end": 249, "sequence": "S" }, "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": 1803568 }, { "name": "end_position", "value": 1803568 }, { "name": "reference_allele", "value": "C" }, { "name": "alternate_allele", "value": "G" }, { "name": "cdna_change", "value": "c.746C>G" }, { "name": "protein_change", "value": "p.S249C" }, { "name": "variant_annotation", "value": "Missense" }, { "name": "exon", "value": 6 }, { "name": "rsid", "value": "rs121913483" }, { "name": "hgvsg", "value": "4:g.1803568C>G" }, { "name": "hgvsc", "value": "ENST00000260795.2:c.746C>G" } ] } } ], "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). 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