{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A874", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004331, "timestamp_received": "2026-09-25T01:17:17.028886+00:00Z", "timestamp_returned": "2026-09-25T01:17:17.033217+00:00Z", "trace_id": "855c8dc2-b6fa-4a98-991e-5d48a58d56f8" }, "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:modeyso:0:0", "type": "Statement", "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on 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. The underlying trials, including ONC018 (NCT03134131), assessed H3 K27M status through either IHC or sequencing for patient eligibility. 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FDA.", "title": null, "aliases": [], "description": "Chimerix, Inc. Modeyso (dordaviprone) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf. Revised August 2025. Accessed October 2, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219876" ], "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": "Chimerix, Inc.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Modeyso", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "dordaviprone", "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:ncit:C182151", "conceptType": "Disease", "name": "Diffuse Midline Glioma", "mappings": [ { "relation": "narrowMatch", "coding": { "id": "coding:oncotree:DIFG", "code": "DIFG", "name": "Diffuse Glioma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=DIFG" ] } } ], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:ncit:C182151", "code": "C182151", "name": "Diffuse Midline Glioma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C182151" ] } }, "objectTherapeutic": { "id": "tx:ncit:C113792", "conceptType": "Therapy", 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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:modeyso:0", "type": "Indication", "description": "MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.", "contributions": [ { "id": "ctrb:vanallenlab:2025-10-02:0", "type": "Contribution", "description": "On 2025-08-06, the US FDA granted accelerated approval to Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.", "date": "2025-10-02", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:fda:2025-08-06:0", "type": "Contribution", "description": "Indication received accelerated approval.", "date": "2025-08-06", "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:modeyso", "type": "Document", "documentType": "Regulatory approval", "name": "Modeyso (dordaviprone) [package insert]. 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