{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:truqap:0:5 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Atruqap%3A0%3A5", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002117, "timestamp_received": "2026-10-16T23:35:32.295438+00:00Z", "timestamp_returned": "2026-10-16T23:35:32.297555+00:00Z", "trace_id": "4abbb953-8b4f-4c6e-b98f-a3f1ab7f3e90" }, "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:truqap:0:5", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized capivasertib in combination with fulvestrant for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. Capivasertib's product information further states that in pre- or perimenopausal women, capivasertib plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. The product information further states that, for men, administration of LHRH agonist according to current clinical practices should be considered. This indication is based on CAPItello-291, a randomized, double-blind, placebo-controlled trial, where HER2-negative status was defined as either IHC 0 or 1+, or IHC 2+/ISH-, and qualifying alterations were activating mutations in PIK3CA and AKT1 and inactivating mutations in PTEN.", "contributions": [ { "id": "ctrb:vanallenlab:2024-10-20:0", "type": "Contribution", "description": "Adding EMA approvals for use to database", "date": "2024-10-20", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2024-06-17:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2024-06-17", "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:truqap", "type": "Document", "documentType": "Regulatory approval", "name": "Truqap (capivasertib) [product information]. EMA.", "title": null, "aliases": [], "description": "AstraZeneca AB. Truqap (capivasertib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf. Revised July 2024. Accessed October 18, 2024.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/truqap" ], "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": "AstraZeneca AB.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Truqap", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "capivasertib", "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:C9245", "conceptType": "Disease", "name": "Invasive Breast Carcinoma", "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:oncotree:BRCA", "code": "BRCA", "name": "Invasive Breast Carcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Invasive+Breast+Carcinoma+%28BRCA%29" ] } } ], "extensions": [ { "name": "solid_tumor", "value": true, "description": "Boolean value for if this tumor type is categorized as a solid tumor." } ], "primaryCoding": { "id": "coding:ncit:C9245", "code": "C9245", "name": "Invasive Breast Carcinoma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C9245" ] } }, "objectTherapeutic": { "id": "txgrp:12", "membershipOperator": "AND", "therapies": [ { "id": "tx:ncit:C102564", "conceptType": "Therapy", "name": "Capivasertib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:2669967", "code": "2669967", "name": "capivasertib", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2669967" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:747200", "code": "747200", "name": "capivasertib", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/747200" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "PI3K/AKT/mTOR 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" } ], 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the therapy." }, { "name": "therapy_type", "value": "Hormone therapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ], "primaryCoding": { "id": "coding:ncit:C1379", "code": "C1379", "name": "Fulvestrant", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1379" ] } } ] }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:1", "present": true, "subject": { "id": "bmkr:1", "type": "CategoricalVariant", "name": "ER positive", "constraints": [], "extensions": [ { "name": "biomarker_type", "value": "Protein expression" }, { "name": "marker", "value": "Estrogen receptor (ER)" }, { "name": "unit", "value": "status" }, { "name": "equality", "value": "=" }, { "name": "value", "value": "Positive" } ] } }, { "id": "bmkr.criterion:2", "present": true, "subject": { "id": "bmkr:2", "type": 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