{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A880", "status": "success", "status_code": 200, "timestamp_elapsed": 0.00419, "timestamp_received": "2026-09-25T00:14:02.960403+00:00Z", "timestamp_returned": "2026-09-25T00:14:02.964593+00:00Z", "trace_id": "253dbd77-9e6e-4a5b-b7c6-165dfa4e55ca" }, "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:komzifti:0:0", "type": "Statement", "description": "The U.S. Food and Drug Administration (FDA) granted approval to ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. This approval is based on NCT04067336, an open-label, single-arm, multicenter clinical trial of 112 patients where eligibility criteria included NPM1 mutations, including Type A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG) mutations and other NPM1 mutations likely to result in cytoplasmic localization of the NPM1 protein.", "contributions": [ { "id": "ctrb:vanallenlab:2025-12-23:1", "type": "Contribution", "description": "On 2025-11-13, the US FDA granted regular approval to ziftomenib for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with susceptible NPM1 mutation who have no satisfactory alternative treatment options.", "date": "2025-12-23", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2025-11-13:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2025-11-13", "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:komzifti", "type": "Document", "documentType": "Regulatory approval", "name": "Komzifti (ziftomenib) [package insert]. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:oncotree:AML", "conceptType": "Disease", "name": "Acute Myeloid Leukemia", "mappings": [], "extensions": [ { "name": "solid_tumor", "value": false, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:oncotree:AML", "code": "AML", "name": "Acute Myeloid Leukemia", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=AML" ] } }, "objectTherapeutic": { "id": "tx:ncit:C164227", "conceptType": "Therapy", "name": "Ziftomenib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2725985", "code": "2725985", "name": "ziftomenib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2725985" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:37354589", "code": "37354589", "name": "ziftomenib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/37354589" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "Menin 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:C164227", "code": "C164227", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C164227" ] } }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:177", "present": true, "subject": { "id": "bmkr:177", "type": "CategoricalVariant", "name": "NPM1 p.W288Cfs*12", "constraints": [ { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:7910", "conceptType": "Gene", "name": "NPM1", "primaryCoding": { "id": "coding:hgnc:7910", "code": "HGNC:7910", "name": "NPM1", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:7910" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_002520.7", "code": "NM_002520.7", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_002520.7" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:ensembl:ensg00000181163", "code": "ENSG00000181163", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000181163" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:ncbi:4869", "code": "4869", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/4869" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Somatic variant" }, { "name": "chromosome", "value": "5" }, { "name": "start_position", "value": 171410544 }, { "name": "end_position", "value": 171410543 }, { "name": "reference_allele", "value": "-" }, { "name": "alternate_allele", "value": "TCTG" }, { "name": "cdna_change", "value": "c.860_863dup" }, { "name": "protein_change", "value": "p.W288Cfs*12" }, { "name": "variant_annotation", "value": "Frameshift" }, { "name": "exon", "value": "11/11" }, { "name": "rsid", "value": "rs587776806" }, { "name": "hgvsg", "value": "5:g.171410540_171410543dup" }, { "name": "hgvsc", "value": "NM_002520.7:c.860_863dup" } ] } } ], "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:komzifti:0", "type": "Indication", "description": "KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alterantive treatment options.", "contributions": [ { "id": "ctrb:vanallenlab:2025-12-23:1", "type": "Contribution", "description": "On 2025-11-13, the US FDA granted regular approval to ziftomenib for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with susceptible NPM1 mutation who have no satisfactory alternative treatment options.", "date": "2025-12-23", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2025-11-13:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2025-11-13", "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:komzifti", "type": "Document", "documentType": "Regulatory approval", "name": "Komzifti (ziftomenib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Kura Oncology, Inc. Komzifti (ziftomenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf. Revised November 2025. Accessed December 23, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305" ], "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": "Kura Oncology, Inc", "description": "The company that manufactures the cancer drug. 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