{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A904", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004126, "timestamp_received": "2026-09-25T01:17:00.311588+00:00Z", "timestamp_returned": "2026-09-25T01:17:00.315714+00:00Z", "trace_id": "c40ac476-8e79-481e-b855-4b6fd3ec3fee" }, "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": "2026-08-02" }, "data": [ { "id": "stmt:fda:braftovi:3:1", "type": "Statement", "description": "The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This approval was based on NCT04607421, a randomized, active-controlled, open-label, multicenter trial. Braftovi was initially evaluated in combination with cetuximab and mFOLFOX6 and later in combination with cetuximab and FOLFIRI, and the two treatment arms observed an objective response rate of 61% and 64%, respectively. The package insert states that encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", "contributions": [ { "id": "ctrb:fda:2026-02-24:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2026-02-24", "contributor": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." } }, { "id": "ctrb:vanallenlab:2025-01-10:0", "type": "Contribution", "description": "Additional FDA approvals for initial version", "date": "2025-01-10", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2024-12-20:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2024-12-20", "contributor": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." } } ], "reportedIn": [ { "id": "doc:fda:braftovi", "type": "Document", "documentType": "Regulatory approval", "name": "Braftovi (encorafenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf. Revised February 2026. Accessed March 2, 2026.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210496" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." }, "description": "The organization that published this document." }, { "name": "company", "value": "Array BioPharma, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Braftovi", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "encorafenib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2018-06-27", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 210496, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2026-02-24", "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:904", "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:oncotree:COADREAD", "conceptType": "Disease", "name": "Colorectal Adenocarcinoma", "mappings": [], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding: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" ] } }, "objectTherapeutic": { "id": "txgrp:195", "membershipOperator": "AND", "therapies": [ { "id": "tx:ncit:C1723", "conceptType": "Therapy", "name": "Cetuximab", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:318341", "code": "318341", "name": "cetuximab", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=318341" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:4247978", "code": "4247978", "name": "Cetuximab", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/4247978" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:409400001", "code": "409400001", "name": "Cetuximab", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=409400001&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1315411", "code": "1315411", "name": "cetuximab", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1315411" ] } } ], "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" } ], "primaryCoding": { "id": "coding: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" ] } }, { "id": "tx:ncit:C98283", "conceptType": "Therapy", "name": "Encorafenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2049106", "code": "2049106", "name": "encorafenib", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2049106" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:36674339", "code": "36674339", "name": "Encorafenib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/36674339" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:772201002", "code": "772201002", "name": "Encorafenib", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=772201002&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1559914", "code": "1559914", "name": "encorafenib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1559914" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "B-RAF 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:C98283", "code": "C98283", "name": "Encorafenib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C98283" ] } }, { "id": "tx:ncit:C505", "conceptType": "Therapy", "name": "Fluorouracil", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:4492", "code": "4492", "name": "fluorouracil", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=4492" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:4300009", "code": "4300009", "name": "Fluorouracil", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/4300009" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:387172005", "code": "387172005", "name": "Fluorouracil", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387172005&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:955632", "code": "955632", "name": "fluorouracil", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/955632" ] } } ], "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" } ], "primaryCoding": { "id": "coding: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" ] } }, { "id": "tx:ncit:C62040", "conceptType": "Therapy", "name": "Irinotecan", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:51499", "code": "51499", "name": "irinotecan", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=51499" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:4156721", "code": "4156721", "name": "Irinotecan", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/4156721" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:372538008", "code": "372538008", "name": "Irinotecan", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=372538008&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1367268", "code": "1367268", "name": "irinotecan", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1367268" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "Topoisomerase I 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" } ], "primaryCoding": { "id": "coding:ncit:C62040", "code": "C62040", "name": "Irinotecan", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62040" ] } } ] }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:16", "present": true, "subject": { "id": "bmkr:16", "type": "CategoricalVariant", "name": "BRAF p.V600E", "constraints": [ { "type": "DefiningAlleleConstraint", "allele": { "id": "ga4gh:VA.j4XnsLZcdzDIYa5pvvXM7t1wn9OITr0L", "type": "Allele", "name": "NP_004324.2:p.Val600Glu", "aliases": [ "NP_004324.2:p.V600E", "BRAF p.V600E" ], "description": "VRS variation of NP_004324.2:p.Val600Glu", "digest": "j4XnsLZcdzDIYa5pvvXM7t1wn9OITr0L", "expressions": [ { "syntax": "hgvs.p", "value": "NP_004324.2:p.Val600Glu", "extensions": [ { "name": "hgvs.p_short", "value": "p.V600E" } ] } ], "location": { "id": "ga4gh:SL.t-3DrWALhgLdXHsupI-e-M00aL3HgK3y", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Amino acid position 600 of the Refseq protein NP_004324.2, which is the protein product of the MANE Select coding transcript for BRAF (refseq:NM_004333.6).", "digest": "t-3DrWALhgLdXHsupI-e-M00aL3HgK3y", "sequenceReference": { "id": "ga4gh:SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "type": "SequenceReference", "name": "NP_004324.2", "aliases": [ "ensembl:ENSP00000288602.6", "ga4gh:SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "refseq:NP_004324.2" ], "description": "The protein product of the MANE Select coding transcript for BRAF (refseq:NM_004333.6), corresponding to the Refseq protein accession NP_004324.2.", "moleculeType": "protein", "refgetAccession": "SQ.cQvw4UsHHRRlogxbWCB8W-mKD4AraM9y", "residueAlphabet": "aa" }, "start": 599, "end": 600, "sequence": "V" }, "state": { "type": "LiteralSequenceExpression", "sequence": "E" } }, "relations": [] }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:1097", "conceptType": "Gene", "name": "BRAF", "primaryCoding": { "id": "coding:hgnc:1097", "code": "HGNC:1097", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1097" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000157764", "code": "ENSG00000157764", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000157764" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:673", "code": "673", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/673" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_004333.6", "code": "NM_004333.6", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004333.6" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Somatic variant" }, { "name": "chromosome", "value": "7" }, { "name": "start_position", "value": 140453136 }, { "name": "end_position", "value": 140453136 }, { "name": "reference_allele", "value": "A" }, { "name": "alternate_allele", "value": "T" }, { "name": "cdna_change", "value": "c.1799T>A" }, { "name": "protein_change", "value": "p.V600E" }, { "name": "variant_annotation", "value": "Missense" }, { "name": "exon", "value": 15 }, { "name": "rsid", "value": "rs113488022" }, { "name": "hgvsg", "value": "7:g.140453136A>T" }, { "name": "hgvsc", "value": "ENST00000288602.6:c.1799T>A" } ] } } ], "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": "25.01d", "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:fda:braftovi:3", "type": "Indication", "description": "BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.", "contributions": [ { "id": "ctrb:fda:2026-02-24:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2026-02-24", "contributor": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." } }, { "id": "ctrb:vanallenlab:2025-01-10:0", "type": "Contribution", "description": "Additional FDA approvals for initial version", "date": "2025-01-10", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2024-12-20:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2024-12-20", "contributor": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." } } ], "reportedIn": [ { "id": "doc:fda:braftovi", "type": "Document", "documentType": "Regulatory approval", "name": "Braftovi (encorafenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf. Revised February 2026. Accessed March 2, 2026.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210496" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "agent:org:fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States." }, "description": "The organization that published this document." }, { "name": "company", "value": "Array BioPharma, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Braftovi", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "encorafenib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2018-06-27", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 210496, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2026-02-24", "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." } ] } ] }