{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A365", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004173, "timestamp_received": "2026-09-25T00:14:04.352536+00:00Z", "timestamp_returned": "2026-09-25T00:14:04.356709+00:00Z", "trace_id": "b50ae46a-d0e9-4342-8483-e5fdf880a5d3" }, "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:gavreto:1:0", "type": "Statement", "description": "The U.S. Food and Drug Administration granted accelerated approval to pralsetinib for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 trial(s). This indication is based on ARROW (NCT03037385), a multicenter, open-label, multi-cohort clinical trial where all enrolled patients had papillary thyroid cancer.", "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:2021-11-10:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2021-11-10", "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:gavreto", "type": "Document", "documentType": "Regulatory approval", "name": "Gavreto (pralsetinib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Blueprint Medicines Corporation. Gavreto (pralsetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf. Revised March 2024. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213721" ], "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": "Blueprint Medicines Corporation.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Gavreto", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "pralsetinib", "description": "The generic name of the cancer drug, per this document. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:oncotree:THPA", "conceptType": "Disease", "name": "Papillary Thyroid Cancer", "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:THPA", "code": "THPA", "name": "Papillary Thyroid Cancer", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=THPA" ] } }, "objectTherapeutic": { "id": "tx:ncit:C132295", "conceptType": "Therapy", "name": "Pralsetinib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2394936", "code": "2394936", "name": "pralsetinib", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2394936" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:619847", "code": "619847", "name": "Pralsetinib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/619847" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:926312002", "code": "926312002", "name": "Pralsetinib", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=926312002&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:37002765", "code": "37002765", "name": "pralsetinib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/37002765" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "RET 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:C132295", "code": "C132295", "name": "Pralsetinib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C132295" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:18", "present": true, "subject": { "id": "bmkr:18", "type": "CategoricalVariant", "name": "v::RET", "constraints": [ { "type": "AdjacencyConstraint", "orderKnown": false, "adjoinedElements": [ { "id": "gene:hgnc:9967", "conceptType": "Gene", "name": "RET", "primaryCoding": { "id": "coding:hgnc:9967", "code": "HGNC:9967", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:9967" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000165731", "code": "ENSG00000165731", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000165731" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:5979", "code": "5979", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/5979" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_020975.6", "code": "NM_020975.6", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_020975.6" ] } } ] }, { "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). 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This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", "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:2021-11-10:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2021-11-10", "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:gavreto", "type": "Document", "documentType": "Regulatory approval", "name": "Gavreto (pralsetinib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Blueprint Medicines Corporation. Gavreto (pralsetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf. Revised March 2024. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213721" ], "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": "Blueprint Medicines Corporation.", "description": "The company that manufactures the cancer drug. 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