{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A349", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004118, "timestamp_received": "2026-09-25T01:17:02.521662+00:00Z", "timestamp_returned": "2026-09-25T01:17:02.525780+00:00Z", "trace_id": "6703eba0-dd0b-4974-af79-299796b0033b" }, "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:pemazyre:0:1", "type": "Statement", "description": "The U.S. Food and Drug Administration granted accelerated approval to pemigatinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. The product label states 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 a 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:2020-04-17:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2020-04-17", "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:pemazyre", "type": "Document", "documentType": "Regulatory approval", "name": "Pemazyre (pemigatinib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf. Revised August 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736" ], "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": "Incyte Corporation.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Pemazyre", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "pemigatinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": null, "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 213736, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2020-04-17", "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:349", "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:CHOL", "conceptType": "Disease", "name": "Cholangiocarcinoma", "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:CHOL", "code": "CHOL", "name": "Cholangiocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=CHOL" ] } }, "objectTherapeutic": { "id": "tx:ncit:C121553", "conceptType": "Therapy", "name": "Pemigatinib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2359268", "code": "2359268", "name": "pemigatinib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2359268" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:37499576", "code": "37499576", "name": "pemigatinib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/37499576" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:871699001", "code": "871699001", "name": "Pemigatinib", "system": "SNOMED", "systemVersion": "2025-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=871699001&edition=MAIN/2025-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:3667002", "code": "3667002", "name": "Pemigatinib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/3667002" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "FGFR 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:C121553", "code": "C121553", "name": "Pemigatinib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C121553" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:53", "present": true, "subject": { "id": "bmkr:53", "type": "CategoricalVariant", "name": "FGFR2 rearrangements", "constraints": [ { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:3689", "conceptType": "Gene", "name": "FGFR2", "primaryCoding": { "id": "coding:hgnc:3689", "code": "HGNC:3689", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3689" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000066468", "code": "ENSG00000066468", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000066468" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:2263", "code": "2263", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/2263" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_000141.5", "code": "NM_000141.5", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_000141.5" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Rearrangement" } ] } } ], "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:pemazyre:0", "type": "Indication", "description": "PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. 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 a 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:2020-04-17:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2020-04-17", "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:pemazyre", "type": "Document", "documentType": "Regulatory approval", "name": "Pemazyre (pemigatinib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf. Revised August 2022. Accessed October 30, 2024.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736" ], "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": "Incyte Corporation.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Pemazyre", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "pemigatinib", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": null, "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 213736, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2020-04-17", "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." } ] } ] }