{ "meta": { "data_length": 1, "message": "Statement id stmt:ema:akeega:1:3 retrieved successfully", "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Aema%3Aakeega%3A1%3A3", "status": "success", "status_code": 200, "timestamp_elapsed": 0.002038, "timestamp_received": "2026-10-16T22:58:14.104334+00:00Z", "timestamp_returned": "2026-10-16T22:58:14.106372+00:00Z", "trace_id": "e50597e4-d5a1-47bf-a3fe-929553cb9512" }, "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:akeega:1:3", "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate (Akeega) in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline or somatic). This indication is based on the AMPLITUDE trial (NCT04497844), a phase 3, randomized, double-blind, placebo-controlled multinational study. Patients were required to have started ADT >= 14 days prior to randomization and have been willing to continue ADT throughout the treatment phase. Specific ADT was the choice of which was at the discretion of the investigator.", "contributions": [ { "id": "ctrb:vanallenlab:2026-08-02:0", "type": "Contribution", "description": "Initial curation of into moalmanac-db", "date": "2026-08-02", "contributor": { "id": "agent:user:vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute" } }, { "id": "ctrb:ema:2026-03-05:0", "type": "Contribution", "description": "Indication received approval from the European Commission.", "date": "2026-03-05", "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:akeega", "type": "Document", "documentType": "Regulatory approval", "name": "Akeega (abiraterone acetate and niraparib) [product information]. EMA.", "title": null, "aliases": [], "description": "Janssen-Cilag International N.V. Akeega (abiraterone acetate and niraparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.", "urls": [ "https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf", "https://www.ema.europa.eu/en/medicines/human/EPAR/akeega" ], "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": "Janssen-Cilag International N.V.", "description": "The company that manufactures the cancer drug. 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See the 'biomarkers' extension for biomarkers associated with this Proposition." }, "conditionQualifier": { "id": "dis:ncit:C2919", "conceptType": "Disease", "name": "Prostate Adenocarcinoma", "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:oncotree:PRAD", "code": "PRAD", "name": "Prostate Adenocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2025_10_03", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2025_10_03&field=NAME&search=Prostate+Adenocarcinoma+%28PRAD%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:C2919", "code": "C2919", "name": "Prostate Adenocarcinoma", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "26.08e", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2919" ] } }, "objectTherapeutic": { "id": "txgrp:4", "membershipOperator": "AND", "therapies": [ { "id": "tx:ncit:C68845", "conceptType": "Therapy", "name": "Abiraterone acetate", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:1100071", "code": "1100071", "name": "abiraterone acetate", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1100071" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:46274231", "code": "46274231", "name": "abiraterone acetate", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/46274231" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "Antiandrogen" ], "description": "Associated therapeutic strategy or mechanism of action of 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": 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refseq:NP_000050.3, the protein product of the MANE Select coding transcript for BRCA2 (refseq:NM_000059.4).", "digest": "7RukGUDX8Q-lC8U7OIIL3hRCBfXr7tji", "sequenceReference": { "id": "ga4gh:SQ.A6rzuv6kdsuIp6gy6fykzgzyJe9NJOC9", "type": "SequenceReference", "name": "NP_000050.3", "aliases": [ "ensembl:ENSP00000369497.3", "ga4gh:SQ.A6rzuv6kdsuIp6gy6fykzgzyJe9NJOC9", "refseq:NP_000050.3" ], "description": "The protein product of the MANE Select coding transcript for BRCA2 (refseq:NM_000059.4), corresponding to the Refseq protein accession NP_000050.3.", "moleculeType": "protein", "refgetAccession": "SQ.A6rzuv6kdsuIp6gy6fykzgzyJe9NJOC9", "residueAlphabet": "aa" }, "start": 0, "end": 3418, "sequence": null }, "relations": [], "matchCharacteristic": { "primaryCoding": { "code": "is_within", "system": "ga4gh-gks-term:location-match" } } }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:1101", "conceptType": "Gene", "name": "BRCA2", "primaryCoding": { "id": 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Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Akeega", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "abiraterone acetate and niraparib", "description": "The generic name of the cancer drug, per this document. 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