{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?proposition_id=556&agent_id=fda&agent_id=ema", "status": "success", "status_code": 200, "timestamp_elapsed": 0.033683, "timestamp_received": "2026-04-12T05:49:35.337301+00:00Z", "timestamp_returned": "2026-04-12T05:49:35.370984+00:00Z", "trace_id": "486b3ca6-d3b0-4694-aaf8-32a3b6b37bea" }, "service": { "github": "https://github.com/vanallenlab/moalmanac-db", "name": "Molecular Oncology Almanac", "license": "GPL-2.0", "release": "draft", "url": "https://dev.moalmanac.org", "last_updated": "2026-04-09" }, "data": [ { "id": 693, "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized cetuximab in combination with FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) for the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer.", "contributions": [ { "id": 13, "type": "Contribution", "agent": { "id": "vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute", "last_updated": null, "url": null }, "description": "Adding EMA approvals for use to database", "date": "2024-10-20" } ], "reportedIn": [ { "id": "doc:ema.erbitux", "type": "Document", "documentType": "Regulatory approval", "name": "Erbitux (cetuximab) [product information]. EMA.", "title": null, "aliases": [], "description": "Merck Europe B.V. Erbitux (cetuximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf. Revised May 2022. Accessed March 12, 2024.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux", "https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Merck Europe B.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Erbitux", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "cetuximab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2009-07-14", "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": "2022-05-25", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } ], "direction": "supports", "indication": { "id": "ind:ema.erbitux:2", "indication": "Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in first-line in combination with FOLFOX.", "initial_approval_date": "2012-02-20", "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/erbitux-h-c-558-ii-0047-epar-assessment-report-variation_en.pdf", "description": "The European Medicines Agency (EMA) has authorized cetuximab in combination with FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) for the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer.", "raw_biomarkers": null, "raw_cancer_type": "Colorectal cancer", "raw_therapeutics": "Erbitux (cetuximab) in combination with 5-fluorouracil and oxaliplatin", "icd10": null, "regimen_code": null, "reimbursement_category": null, "reimbursement_date": null, "reimbursement_details": null, "date_regular_approval": null, "date_accelerated_approval": null, "document": { "id": "doc:ema.erbitux", "type": "Document", "documentType": "Regulatory approval", "name": "Erbitux (cetuximab) [product information]. EMA.", "title": null, "aliases": [], "description": "Merck Europe B.V. Erbitux (cetuximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf. Revised May 2022. Accessed March 12, 2024.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux", "https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Merck Europe B.V.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Erbitux", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "cetuximab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2009-07-14", "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": "2022-05-25", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } }, "proposition": { "id": 556, "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "biomarkers": [ { "id": 26, "name": "Wild type HRAS", "genes": [ { "id": 27, "name": "HRAS", "primaryCoding": { "id": "hgnc:5173", "code": "HGNC:5173", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:5173" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_005343.4", "code": "NM_005343.4", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005343.4" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000174775", "code": "ENSG00000174775", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000174775" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:3265", "code": "3265", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/3265" ] } } ], "extensions": [ { "name": "location", "value": "11p15.5" }, { "name": "location_sortable", "value": "11p15.5" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 27, "name": "Wild type NRAS", "genes": [ { "id": 33, "name": "NRAS", "primaryCoding": { "id": "hgnc:7989", "code": "HGNC:7989", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:7989" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_002524.5", "code": "NM_002524.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_002524.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000213281", "code": "ENSG00000213281", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000213281" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:4893", "code": "4893", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/4893" ] } } ], "extensions": [ { "name": "location", "value": "1p13.2" }, { "name": "location_sortable", "value": "01p13.2" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 24, "name": "EGFR positive", "genes": [], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Protein expression" }, { "name": "present", "value": true }, { "name": "marker", "value": "EGFR" }, { "name": "unit", "value": "status" }, { "name": "equality", "value": "=" }, { "name": "value", "value": "Positive" } ] }, { "id": 25, "name": "Wild type KRAS", "genes": [ { "id": 31, "name": "KRAS", "primaryCoding": { "id": "hgnc:6407", "code": "HGNC:6407", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:6407" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_004985.5", "code": "NM_004985.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004985.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000133703", "code": "ENSG00000133703", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000133703" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:3845", "code": "3845", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/3845" ] } } ], "extensions": [ { "name": "location", "value": "12p12.1" }, { "name": "location_sortable", "value": "12p12.1" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] } ], "subjectVariant": {}, "conditionQualifier": { "id": 15, "conceptType": "Disease", "name": "Colorectal Adenocarcinoma", "primaryCoding": { "id": "oncotree:COADREAD", "code": "COADREAD", "name": "Colorectal Adenocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=COADREAD" ] }, "mappings": [] }, "objectTherapeutic": { "id": 109, "membership_operator": "AND", "therapies": [ { "id": 19, "conceptType": "Drug", "name": "Cetuximab", "primaryCoding": { "id": "ncit:C1723", "code": "C1723", "name": "Cetuximab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1723" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "EGFR 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" } ] }, { "id": 28, "conceptType": "Drug", "name": "Oxaliplatin", "primaryCoding": { "id": "ncit:C1181", "code": "C1181", "name": "Oxaliplatin", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1181" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Platinum-based chemotherapy" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Chemotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] }, { "id": 29, "conceptType": "Drug", "name": "Fluorouracil", "primaryCoding": { "id": "ncit:C505", "code": "C505", "name": "Fluorouracil", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C505" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Thymidylate synthase inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Chemotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] } ] } } } ] }