{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:augtyro:1:1 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Aaugtyro%3A1%3A1", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002043, "timestamp_received": "2026-10-16T22:58:08.956110+00:00Z", "timestamp_returned": "2026-10-16T22:58:08.958153+00:00Z", "trace_id": "b778e3fe-f68a-4f92-994a-f4cbd417fcd8" }, "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:augtyro:1:1", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized repotrectinib for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expression NTRK gene fusions, and (i) who have received a prior NTRK inhibitor, or (ii) have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinial benefit, or have been exhausted.", "contributions": [ { "id": "ctrb:vanallenlab:2025-09-08:0", "type": "Contribution", "description": "On 2025-01-28, the EMA provided conditional approval to Augtyro (repotrectinib) for two treatment indications: (i) adult patients with ROS1-positive non-small cell lung cancer, or (ii) adults and pediatric patients aged 12 and older with solid tumors that have an NTRK gene fusion.", "date": "2025-09-08", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2025-01-13:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2025-01-13", "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:augtyro", "type": "Document", "documentType": "Regulatory approval", "name": "Augtyro (repotrectinib) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Augtyro (repotrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf. Revised January 2025. Accessed September 8, 2025.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro" ], "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": "Bristol-Myers Squibb Pharma EEIG", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Augtyro", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "repotrectinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2025-01-28", "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": "2025-01-28", "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:370", "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: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": "26.08e", "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": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C133821" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:64", "present": true, "subject": { "id": "bmkr:64", "type": "CategoricalVariant", "name": "v::NTRK2", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": false, "adjoinedElements": [ { "id": "gene:hgnc:8032", "conceptType": "Gene", "name": "NTRK2", "primaryCoding": { "id": "coding:hgnc:8032", "code": "HGNC:8032", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:8032" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000148053", "code": "ENSG00000148053", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000148053" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:4915", "code": "4915", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/4915" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_006180.6", "code": "NM_006180.6", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_006180.6" ] } } ] }, { "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). 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:augtyro:1", "type": "Indication", "description": "AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumors expression NTRK gene fusions, and (i) who have received a prior NTRK inhibitor, or (ii) have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinial benefit, or have been exhausted.", "contributions": [ { "id": "ctrb:vanallenlab:2025-09-08:0", "type": "Contribution", "description": "On 2025-01-28, the EMA provided conditional approval to Augtyro (repotrectinib) for two treatment indications: (i) adult patients with ROS1-positive non-small cell lung cancer, or (ii) adults and pediatric patients aged 12 and older with solid tumors that have an NTRK gene fusion.", "date": "2025-09-08", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2025-01-13:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2025-01-13", "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:augtyro", "type": "Document", "documentType": "Regulatory approval", "name": "Augtyro (repotrectinib) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Augtyro (repotrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf. Revised January 2025. Accessed September 8, 2025.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro" ], "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": "Bristol-Myers Squibb Pharma EEIG", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Augtyro", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "repotrectinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2025-01-28", "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": "2025-01-28", "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." } ] } ] }