{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:welireg:0:1 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Awelireg%3A0%3A1", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002049, "timestamp_received": "2026-10-16T23:00:14.534321+00:00Z", "timestamp_returned": "2026-10-16T23:00:14.536370+00:00Z", "trace_id": "d1445c29-d7af-4149-8b2f-30c839f9b3f5" }, "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:welireg:0:1", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized belzutifan as a monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable. This indication is based on LITESPARK-004, an open-label phase 2 clinical study in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and who did not require immediate surgery. Patients could also have other VHL disease-associated tumors such as CNS hemangioblastomas and pNETs. VHL-associated disease was based on the presence of a VHL germline alteration.", "contributions": [ { "id": "ctrb:vanallenlab:2026-05-05:1", "type": "Contribution", "description": "Initial curation of EMA's approval of Welireg (belzutifan)", "date": "2026-05-05", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2025-02-12:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2025-02-12", "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:welireg", "type": "Document", "documentType": "Regulatory approval", "name": "Welireg (belzutifan) [product information]. EMA.", "title": null, "aliases": [], "description": "Merck Sharp & Dohme B.V. Welireg (belzutifan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf.pdf. Revised January 2026. Accessed May 5, 2026.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/welireg" ], "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": "Merck Sharp & Dohme B.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Welireg", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "belzutifan", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2025-02-27", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": "EMEA/H/C/005636", "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2026-01-13", "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:913", "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:C7007", "conceptType": "Disease", "name": "Central Nervous System Hemangioblastoma", "mappings": [ { "relation": "broadMatch", "coding": { "id": "coding:oncotree:HMBL", "code": "HMBL", "name": "Hemangioblastoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Hemangioblastoma+%28HMBL%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:C7007", "code": "C7007", "name": "Central Nervous System Hemangioblastoma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C7007" ] } }, "objectTherapeutic": { "id": "tx:ncit:C135627", "conceptType": "Therapy", "name": "Belzutifan", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2567226", "code": "2567226", "name": "belzutifan", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2567226" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:701696", "code": "701696", "name": "belzutifan", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/701696" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "HIF-2a 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:C135627", "code": "C135627", "name": "Belzutifan", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C135627" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:180", "present": true, "subject": { "id": "bmkr:180", "type": "CategoricalVariant", "name": "VHL pathogenic variants", "constraints": [ { "type": "DefiningLocationConstraint", "location": { "id": "ga4gh:SL.4ZL9FBDsZlXDnOHo7yDCm6OamB2fFdbe", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Sequence spanning the length of refseq:NP_000542.1, the protein product of the MANE Select coding transcript for VHL (refseq:NM_000551.4).", "digest": "4ZL9FBDsZlXDnOHo7yDCm6OamB2fFdbe", "sequenceReference": { "id": "ga4gh:SQ.z-Oa0pZkJ6GHJHOYM7h5mY_umc0SJzTu", "type": "SequenceReference", "name": "NP_000542.1", "aliases": [ "ensembl:ENSP00000256474.2", "ga4gh:SQ.z-Oa0pZkJ6GHJHOYM7h5mY_umc0SJzTu", "refseq:NP_000542.1" ], "description": "The protein product of the MANE Select coding transcript for VHL (refseq:NM_000551.4), corresponding to the Refseq protein accession NP_000542.1.", "moleculeType": "protein", "refgetAccession": "SQ.z-Oa0pZkJ6GHJHOYM7h5mY_umc0SJzTu", "residueAlphabet": "aa" }, "start": 0, "end": 213, "sequence": null }, "relations": [], "matchCharacteristic": { "primaryCoding": { "code": "is_within", "system": "ga4gh-gks-term:location-match" } } }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:12687", "conceptType": "Gene", "name": "VHL", "primaryCoding": { "id": "coding:hgnc:12687", "code": "HGNC:12687", "name": "VHL", "system": "https://genenames.org", "systemVersion": "2026-05-05", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:76" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000134086", "code": "ENSG00000134086", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000134086" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:7428", "code": "7428", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/7428" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_000551.4", "code": "NM_000551.4", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_000551.4" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Germline variant" }, { "name": "chromosome", "value": "3" }, { "name": "start_position", "value": null }, { "name": "end_position", "value": null }, { "name": "reference_allele", "value": null }, { "name": "alternate_allele", "value": null }, { "name": "cdna_change", "value": null }, { "name": "protein_change", "value": null }, { "name": "variant_annotation", "value": null }, { "name": "exon", "value": null }, { "name": "rsid", "value": null }, { "name": "hgvsg", "value": null }, { "name": "hgvsc", "value": null }, { "name": "requires_pathogenic", "value": true } ] } } ], "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:welireg:0", "type": "Indication", "description": "Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.", "contributions": [ { "id": "ctrb:vanallenlab:2026-05-05:1", "type": "Contribution", "description": "Initial curation of EMA's approval of Welireg (belzutifan)", "date": "2026-05-05", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2025-02-12:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2025-02-12", "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:welireg", "type": "Document", "documentType": "Regulatory approval", "name": "Welireg (belzutifan) [product information]. EMA.", "title": null, "aliases": [], "description": "Merck Sharp & Dohme B.V. Welireg (belzutifan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf.pdf. Revised January 2026. Accessed May 5, 2026.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/welireg" ], "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": "Merck Sharp & Dohme B.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Welireg", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "belzutifan", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2025-02-27", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": "EMEA/H/C/005636", "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2026-01-13", "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." } ] } ] }