{ "meta": { "data_length": 1, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A16", "status": "success", "status_code": 200, "timestamp_elapsed": 0.004672, "timestamp_received": "2026-09-25T00:14:22.689348+00:00Z", "timestamp_returned": "2026-09-25T00:14:22.694020+00:00Z", "trace_id": "7de82a74-4941-48dd-9919-8f9de869f977" }, "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:akeega:0:1", "type": "Statement", "description": "The U.S. Food and Drug Administration (FDA) granted approval to Akeega (abiraterone acetate with niraparib) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for Akeega.", "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:2023-08-11:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2023-08-11", "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:akeega", "type": "Document", "documentType": "Regulatory approval", "name": "Akeega (abiraterone acetate and niraparib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Janssen Biotech, Inc. Akeega (abiraterone acetate and niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf. Revised December 2025. Accessed February 5, 2026.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216793" ], "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": "Janssen Biotech, Inc.", "description": "The company that manufactures the cancer drug. 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. 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": 216793, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-12-12", "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:16", "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:PRAD", "conceptType": "Disease", "name": "Prostate Adenocarcinoma", "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:PRAD", "code": "PRAD", "name": "Prostate Adenocarcinoma", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=PRAD" ] } }, "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:44783577", "code": "44783577", "name": "Abiraterone acetate", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/44783577" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:699679004", "code": "699679004", "name": "Abiraterone acetate", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=699679004&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "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": { "id": "coding:ncit:C68845", "code": "C68845", "name": "Abiraterone Acetate", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68845" ] } }, { "id": "tx:ncit:C80059", "conceptType": "Therapy", "name": "Niraparib", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:1918231", "code": "1918231", "name": "niraparib", "system": "RxNorm", "systemVersion": "20250602", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1918231" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:37116802", "code": "37116802", "name": "Niraparib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/37116802" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:733733005", "code": "733733005", "name": "Niraparib", "system": "SNOMED", "systemVersion": "2026-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=733733005&edition=MAIN/2026-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1593861", "code": "1593861", "name": "niraparib", "system": "OMOP", "systemVersion": "v20250827", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1593861" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "PARP 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:C80059", "code": "C80059", "name": "Niraparib", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C80059" ] } }, { "id": "tx:ncit:C770", "conceptType": "Therapy", "name": "Prednisone", "mappings": [ { "relation": "relatedMatch", "coding": { "id": "coding:rxcui:8640", "code": "8640", "name": "prednisone", "system": "RxNorm", "systemVersion": "02-Mar-2026", "iris": [ "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=8640" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:1551099", "code": "1551099", "name": "prednisone", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/1551099" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:sctid:116602009", "code": "116602009", "name": "Prednisone", "system": "SNOMED", "systemVersion": "2025-03-01", "iris": [ "https://browser.ihtsdotools.org/?perspective=full&conceptId1=116602009&edition=MAIN/2025-03-01&release=&languages=en" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:omop:4023242", "code": "4023242", "name": "Prednisone", "system": "OMOP", "systemVersion": "v20260227", "iris": [ "https://athena.ohdsi.org/search-terms/terms/4023242" ] } } ], "extensions": [ { "name": "therapy_strategy", "value": [ "Corticosteroid" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Chemotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ], "primaryCoding": { "id": "coding:ncit:C770", "code": "C770", "name": "Prednisone", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C770" ] } } ] }, "extensions": [ { "name": "biomarkers", "value": [ { "id": "bmkr.criterion:48", "present": true, "subject": { "id": "bmkr:48", "type": "CategoricalVariant", "name": "BRCA1 pathogenic variants", "constraints": [ { "type": "DefiningLocationConstraint", "location": { "id": "ga4gh:SL.weCy_6qoSvyzu7QVSpaJMaGWcDUKmqXb", "type": "SequenceLocation", "name": null, "aliases": [], "description": "Sequence spanning the length of refseq:NP_009225.1, the protein product of the MANE Select coding transcript for BRCA1 (refseq:NM_007294.4).", "digest": "weCy_6qoSvyzu7QVSpaJMaGWcDUKmqXb", "sequenceReference": { "id": "ga4gh:SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y", "type": "SequenceReference", "name": "NP_009225.1", "aliases": [ "ensembl:ENSP00000350283.3", "ga4gh:SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y", "refseq:NP_009225.1" ], "description": "The protein product of the MANE Select coding transcript for BRCA1 (refseq:NM_007294.4), corresponding to the Refseq protein accession NP_009225.1.", "moleculeType": "protein", "refgetAccession": "SQ.nUzIPnHMyQV52hzgBbKl5vlbSwx8M8_Y", "residueAlphabet": "aa" }, "start": 0, "end": 1863, "sequence": null }, "relations": [], "matchCharacteristic": { "primaryCoding": { "code": "is_within", "system": "ga4gh-gks-term:location-match" } } }, { "type": "FeatureContextConstraint", "featureContext": { "id": "gene:hgnc:1100", "conceptType": "Gene", "name": "BRCA1", "primaryCoding": { "id": "coding:hgnc:1100", "code": "HGNC:1100", "system": "https://genenames.org", "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1100" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "coding:ensembl:ensg00000012048", "code": "ENSG00000012048", "system": "https://www.ensembl.org", "iris": [ "https://www.ensembl.org/id/ENSG00000012048" ] } }, { "relation": "exactMatch", "coding": { "id": "coding:ncbi:672", "code": "672", "system": "https://www.ncbi.nlm.nih.gov/gene", "iris": [ "https://www.ncbi.nlm.nih.gov/gene/672" ] } }, { "relation": "relatedMatch", "coding": { "id": "coding:refseq:NM_007294.4", "code": "NM_007294.4", "system": "https://www.ncbi.nlm.nih.gov/nuccore", "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_007294.4" ] } } ] } } ], "extensions": [ { "name": "biomarker_type", "value": "Germline variant" }, { "name": "chromosome", "value": "17" }, { "name": "start_position", "value": null }, { "name": "end_position", "value": null }, { "name": "reference_allele", "value": null }, { "name": "alternate_allele", "value": null }, { "name": "cdna_change", "value": null }, { "name": "protein_change", "value": null }, { "name": "variant_annotation", "value": null }, { "name": "exon", "value": null }, { "name": "rsid", "value": null }, { "name": "hgvsg", "value": null }, { "name": "hgvsc", "value": null }, { "name": "requires_pathogenic", "value": true } ] } } ], "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:akeega:0", "type": "Indication", "description": "AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA.", "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:2023-08-11:0", "type": "Contribution", "description": "Indication received traditional approval.", "date": "2023-08-11", "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:akeega", "type": "Document", "documentType": "Regulatory approval", "name": "Akeega (abiraterone acetate and niraparib) [package insert]. FDA.", "title": null, "aliases": [], "description": "Janssen Biotech, Inc. Akeega (abiraterone acetate and niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf. Revised December 2025. Accessed February 5, 2026.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216793" ], "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": "Janssen Biotech, Inc.", "description": "The company that manufactures the cancer drug. 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. 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": 216793, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-12-12", "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." } ] } ] }