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The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", "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" } }, { "id": "ctrb:fda:2024-06-13:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2024-06-13", "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:augtyro", "type": "Document", "documentType": "Regulatory approval", "name": "Augtyro (repotrectinib) [package insert]. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:ncit:C132146", "conceptType": "Disease", "name": "Any solid tumor", "mappings": [], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:ncit:C132146", "code": "C132146", "name": "Malignant Solid Neoplasm", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C132146" ] } }, "objectTherapeutic": { "id": "tx:ncit:C133821", "conceptType": "Therapy", "name": "Repotrectinib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2670644", "code": "2670644", "name": "repotrectinib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2670644" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:747362", "code": "747362", "name": "repotrectinib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/747362" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "ROS 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:C133821", "code": "C133821", "name": "Repotrectinib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C133821" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:63", "present": true, "subject": { "id": "bmkr:63", "type": "CategoricalVariant", "name": "v::NTRK1", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": false, "adjoinedElements": [ { "id": "gene:hgnc:8031", "conceptType": "Gene", "name": "NTRK1", "primaryCoding": { "id": "coding:hgnc:8031", "code": "HGNC:8031", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:8031" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000198400", "code": "ENSG00000198400", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000198400" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:4914", "code": "4914", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/4914" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_002529.4", "code": "NM_002529.4", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_002529.4" ] } } ] }, { "type": "UnspecifiedElement" } ] } ], "extensions": [ { "name": "biomarker_type", "value": "Gene fusion" } ] } } ], "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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