{ "meta": { "data_length": 4, "message": "Statements retrieved successfully", "request_url": "http://api.moalmanac.org/statements?proposition_id=174&agent_id=fda&agent_id=ema", "status": "success", "status_code": 200, "timestamp_elapsed": 0.116851, "timestamp_received": "2026-04-12T05:13:15.793239+00:00Z", "timestamp_returned": "2026-04-12T05:13:15.910090+00:00Z", "trace_id": "c7b00d83-5fa3-438e-9ff0-bd69e80d9f46" }, "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": "2026-04-09" }, "data": [ { "id": 589, "type": "Statement", "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "contributions": [ { "id": 0, "type": "Contribution", "agent": { "id": "vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute", "last_updated": null, "url": null }, "description": "Initial access of FDA approvals", "date": "2024-10-30" } ], "reportedIn": [ { "id": "doc:fda.opdivo", "type": "Document", "documentType": "Regulatory approval", "name": "Opdivo (nivolumab) [package insert]. FDA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States.", "extensions": [ { "name": "last_updated", "value": "2026-04-09", "description": "" }, { "name": "url", "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Company.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Opdivo", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "nivolumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2014-12-22", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 125554, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-04-11", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } ], "direction": "supports", "indication": { "id": "ind:fda.opdivo:2", "indication": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.", "initial_approval_date": "2020-05-26", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s082lbl.pdf", "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", "raw_cancer_type": "non-small cell lung cancer", "raw_therapeutics": "nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy", "icd10": null, "regimen_code": null, "reimbursement_category": null, "reimbursement_date": null, "reimbursement_details": null, "date_regular_approval": "2025-05-26", "date_accelerated_approval": null, "document": { "id": "doc:fda.opdivo", "type": "Document", "documentType": "Regulatory approval", "name": "Opdivo (nivolumab) [package insert]. FDA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States.", "extensions": [ { "name": "last_updated", "value": "2026-04-09", "description": "" }, { "name": "url", "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Company.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Opdivo", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "nivolumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2014-12-22", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 125554, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-04-11", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } }, "proposition": { "id": 174, "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "biomarkers": [ { "id": 34, "name": "Wild type ALK", "genes": [ { "id": 2, "name": "ALK", "primaryCoding": { "id": "hgnc:427", "code": "HGNC:427", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:427" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000171094", "code": "ENSG00000171094", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000171094" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:238", "code": "238", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/238" ] } }, { "relation": "relatedMatch", "coding": { "id": "refseq:NM_004304.5", "code": "NM_004304.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004304.5" ] } } ], "extensions": [ { "name": "location", "value": "2p23.2-p23.1" }, { "name": "location_sortable", "value": "02p23.2-p23.1" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 35, "name": "Wild type EGFR", "genes": [ { "id": 17, "name": "EGFR", "primaryCoding": { "id": "hgnc:3236", "code": "HGNC:3236", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_005228.5", "code": "NM_005228.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005228.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000146648", "code": "ENSG00000146648", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000146648" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:1956", "code": "1956", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/1956" ] } } ], "extensions": [ { "name": "location", "value": "7p11.2" }, { "name": "location_sortable", "value": "07p11.2" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] } ], "subjectVariant": {}, "conditionQualifier": { "id": 47, "conceptType": "Disease", "name": "Non-Small Cell Lung Cancer", "primaryCoding": { "id": "oncotree:NSCLC", "code": "NSCLC", "name": "Non-Small Cell Lung Cancer", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=NSCLC" ] }, "mappings": [] }, "objectTherapeutic": { "id": 32, "membership_operator": "AND", "therapies": [ { "id": 35, "conceptType": "Drug", "name": "Paclitaxel", "primaryCoding": { "id": "ncit:C1411", "code": "C1411", "name": "Paclitaxel", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Taxane-based chemotherapy" ], "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" } ] }, { "id": 72, "conceptType": "Drug", "name": "Nivolumab", "primaryCoding": { "id": "ncit:C68814", "code": "C68814", "name": "Nivolumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68814" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "PD-1/PD-L1 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] }, { "id": 37, "conceptType": "Drug", "name": "Carboplatin", "primaryCoding": { "id": "ncit:C1282", "code": "C1282", "name": "Carboplatin", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1282" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Platinum-based chemotherapy" ], "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" } ] }, { "id": 71, "conceptType": "Drug", "name": "Ipilimumab", "primaryCoding": { "id": "ncit:C2654", "code": "C2654", "name": "Ipilimumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2654" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "CTLA-4 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] } ] } } }, { "id": 199, "type": "Statement", "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "contributions": [ { "id": 0, "type": "Contribution", "agent": { "id": "vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute", "last_updated": null, "url": null }, "description": "Initial access of FDA approvals", "date": "2024-10-30" } ], "reportedIn": [ { "id": "doc:fda.yervoy", "type": "Document", "documentType": "Regulatory approval", "name": "Yervoy (ipilimumab) [package insert]. FDA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Company. Yervoy (ipilimumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125377s133lbl.pdf. Revised April 2025. Accessed April 30, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125377s133lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States.", "extensions": [ { "name": "last_updated", "value": "2026-04-09", "description": "" }, { "name": "url", "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Company.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Yervoy", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ipilimumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2011-03-25", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 125377, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-04-11", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } ], "direction": "supports", "indication": { "id": "ind:fda.yervoy:2", "indication": "YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy.", "initial_approval_date": "2020-05-26", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", "raw_cancer_type": "metastatic or recurrent non-small cell lung cancer", "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy", "icd10": null, "regimen_code": null, "reimbursement_category": null, "reimbursement_date": null, "reimbursement_details": null, "date_regular_approval": "2020-05-26", "date_accelerated_approval": null, "document": { "id": "doc:fda.yervoy", "type": "Document", "documentType": "Regulatory approval", "name": "Yervoy (ipilimumab) [package insert]. FDA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Company. Yervoy (ipilimumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125377s133lbl.pdf. Revised April 2025. Accessed April 30, 2025.", "urls": [ "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125377s133lbl.pdf", "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "fda", "type": "Agent", "agentType": "organization", "name": "Food and Drug Administration", "description": "Regulatory agency that approves drugs for use in the United States.", "extensions": [ { "name": "last_updated", "value": "2026-04-09", "description": "" }, { "name": "url", "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Company.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Yervoy", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ipilimumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2011-03-25", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": 125377, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-04-11", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } }, "proposition": { "id": 174, "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "biomarkers": [ { "id": 34, "name": "Wild type ALK", "genes": [ { "id": 2, "name": "ALK", "primaryCoding": { "id": "hgnc:427", "code": "HGNC:427", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:427" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000171094", "code": "ENSG00000171094", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000171094" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:238", "code": "238", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/238" ] } }, { "relation": "relatedMatch", "coding": { "id": "refseq:NM_004304.5", "code": "NM_004304.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004304.5" ] } } ], "extensions": [ { "name": "location", "value": "2p23.2-p23.1" }, { "name": "location_sortable", "value": "02p23.2-p23.1" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 35, "name": "Wild type EGFR", "genes": [ { "id": 17, "name": "EGFR", "primaryCoding": { "id": "hgnc:3236", "code": "HGNC:3236", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_005228.5", "code": "NM_005228.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005228.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000146648", "code": "ENSG00000146648", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000146648" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:1956", "code": "1956", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/1956" ] } } ], "extensions": [ { "name": "location", "value": "7p11.2" }, { "name": "location_sortable", "value": "07p11.2" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] } ], "subjectVariant": {}, "conditionQualifier": { "id": 47, "conceptType": "Disease", "name": "Non-Small Cell Lung Cancer", "primaryCoding": { "id": "oncotree:NSCLC", "code": "NSCLC", "name": "Non-Small Cell Lung Cancer", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=NSCLC" ] }, "mappings": [] }, "objectTherapeutic": { "id": 32, "membership_operator": "AND", "therapies": [ { "id": 35, "conceptType": "Drug", "name": "Paclitaxel", "primaryCoding": { "id": "ncit:C1411", "code": "C1411", "name": "Paclitaxel", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Taxane-based chemotherapy" ], "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" } ] }, { "id": 72, "conceptType": "Drug", "name": "Nivolumab", "primaryCoding": { "id": "ncit:C68814", "code": "C68814", "name": "Nivolumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68814" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "PD-1/PD-L1 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] }, { "id": 37, "conceptType": "Drug", "name": "Carboplatin", "primaryCoding": { "id": "ncit:C1282", "code": "C1282", "name": "Carboplatin", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1282" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Platinum-based chemotherapy" ], "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" } ] }, { "id": 71, "conceptType": "Drug", "name": "Ipilimumab", "primaryCoding": { "id": "ncit:C2654", "code": "C2654", "name": "Ipilimumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2654" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "CTLA-4 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] } ] } } }, { "id": 868, "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "contributions": [ { "id": 13, "type": "Contribution", "agent": { "id": "vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute", "last_updated": null, "url": null }, "description": "Adding EMA approvals for use to database", "date": "2024-10-20" } ], "reportedIn": [ { "id": "doc:ema.opdivo", "type": "Document", "documentType": "Regulatory approval", "name": "Opdivo (nivolumab) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 2025. Accessed September 5, 2025.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo", "https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Pharma EEIG.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Opdivo", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "nivolumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2015-07-16", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-06-02", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } ], "direction": "supports", "indication": { "id": "ind:ema.opdivo:0", "indication": "OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.", "initial_approval_date": "2020-11-25", "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/opdivo-h-c-3985-ws-1783-epar-assessment-report-variation_en.pdf", "description": "The European Medicines Agency (EMA) has authorized nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "raw_biomarkers": null, "raw_cancer_type": "Non-small cell lung cancer", "raw_therapeutics": "Opdivo (nivolumab) in combination with ipilimumab and 2 cycles of platinum-based chemotherapy", "icd10": null, "regimen_code": null, "reimbursement_category": null, "reimbursement_date": null, "reimbursement_details": null, "date_regular_approval": null, "date_accelerated_approval": null, "document": { "id": "doc:ema.opdivo", "type": "Document", "documentType": "Regulatory approval", "name": "Opdivo (nivolumab) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 2025. Accessed September 5, 2025.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo", "https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Pharma EEIG.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Opdivo", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "nivolumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2015-07-16", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-06-02", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } }, "proposition": { "id": 174, "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "biomarkers": [ { "id": 34, "name": "Wild type ALK", "genes": [ { "id": 2, "name": "ALK", "primaryCoding": { "id": "hgnc:427", "code": "HGNC:427", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:427" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000171094", "code": "ENSG00000171094", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000171094" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:238", "code": "238", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/238" ] } }, { "relation": "relatedMatch", "coding": { "id": "refseq:NM_004304.5", "code": "NM_004304.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004304.5" ] } } ], "extensions": [ { "name": "location", "value": "2p23.2-p23.1" }, { "name": "location_sortable", "value": "02p23.2-p23.1" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 35, "name": "Wild type EGFR", "genes": [ { "id": 17, "name": "EGFR", "primaryCoding": { "id": "hgnc:3236", "code": "HGNC:3236", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_005228.5", "code": "NM_005228.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005228.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000146648", "code": "ENSG00000146648", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000146648" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:1956", "code": "1956", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/1956" ] } } ], "extensions": [ { "name": "location", "value": "7p11.2" }, { "name": "location_sortable", "value": "07p11.2" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] } ], "subjectVariant": {}, "conditionQualifier": { "id": 47, "conceptType": "Disease", "name": "Non-Small Cell Lung Cancer", "primaryCoding": { "id": "oncotree:NSCLC", "code": "NSCLC", "name": "Non-Small Cell Lung Cancer", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=NSCLC" ] }, "mappings": [] }, "objectTherapeutic": { "id": 32, "membership_operator": "AND", "therapies": [ { "id": 35, "conceptType": "Drug", "name": "Paclitaxel", "primaryCoding": { "id": "ncit:C1411", "code": "C1411", "name": "Paclitaxel", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Taxane-based chemotherapy" ], "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" } ] }, { "id": 72, "conceptType": "Drug", "name": "Nivolumab", "primaryCoding": { "id": "ncit:C68814", "code": "C68814", "name": "Nivolumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68814" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "PD-1/PD-L1 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] }, { "id": 37, "conceptType": "Drug", "name": "Carboplatin", "primaryCoding": { "id": "ncit:C1282", "code": "C1282", "name": "Carboplatin", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1282" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Platinum-based chemotherapy" ], "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" } ] }, { "id": 71, "conceptType": "Drug", "name": "Ipilimumab", "primaryCoding": { "id": "ncit:C2654", "code": "C2654", "name": "Ipilimumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2654" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "CTLA-4 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] } ] } } }, { "id": 1023, "type": "Statement", "description": "The European Medicines Agency (EMA) has authorized ipilimumab in combination with nivolumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "contributions": [ { "id": 13, "type": "Contribution", "agent": { "id": "vanallenlab", "type": "Agent", "agentType": "contributor", "name": "Van Allen lab", "description": "Van Allen lab, Dana-Farber Cancer Institute", "last_updated": null, "url": null }, "description": "Adding EMA approvals for use to database", "date": "2024-10-20" } ], "reportedIn": [ { "id": "doc:ema.yervoy", "type": "Document", "documentType": "Regulatory approval", "name": "Yervoy (ipilimumab) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Yervoy (ipilimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf. Revised March 2025. Accessed September 5, 2025.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy", "https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Pharma EEIG.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Yervoy", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ipilimumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2011-07-25", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-03-17", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } ], "direction": "supports", "indication": { "id": "ind:ema.yervoy:0", "indication": "YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.", "initial_approval_date": "2020-11-20", "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/yervoy-h-c-ws-1783-epar-assessment-report-variation_en.pdf", "description": "The European Medicines Agency (EMA) has authorized ipilimumab in combination with nivolumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", "raw_biomarkers": null, "raw_cancer_type": "Non-small cell lung cancer", "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab and 2 cycles of platinum-based chemotherapy", "icd10": null, "regimen_code": null, "reimbursement_category": null, "reimbursement_date": null, "reimbursement_details": null, "date_regular_approval": null, "date_accelerated_approval": null, "document": { "id": "doc:ema.yervoy", "type": "Document", "documentType": "Regulatory approval", "name": "Yervoy (ipilimumab) [product information]. EMA.", "title": null, "aliases": [], "description": "Bristol-Myers Squibb Pharma EEIG. Yervoy (ipilimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf. Revised March 2025. Accessed September 5, 2025.", "urls": [ "https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy", "https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf" ], "doi": null, "pmid": null, "extensions": [ { "name": "agent", "value": { "id": "ema", "type": "Agent", "agentType": "organization", "name": "European Medicines Agency", "description": "Regulatory agency that approves medicines for use in the European Union.", "extensions": [ { "name": "last_updated", "value": "2025-10-01", "description": "" }, { "name": "url", "value": "https://www.ema.europa.eu/en/medicines", "description": "" } ] }, "description": "The organization that published this document." }, { "name": "company", "value": "Bristol-Myers Squibb Pharma EEIG.", "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents." }, { "name": "drug_name_brand", "value": "Yervoy", "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "drug_name_generic", "value": "ipilimumab", "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents." }, { "name": "first_publication_date", "value": "2011-07-25", "description": "The publication date for the initial version of this document." }, { "name": "identification_number", "value": null, "description": "Identification number used by the publishing organization." }, { "name": "publication_date", "value": "2025-03-17", "description": "The publication date for the document." }, { "name": "status", "value": "Active", "description": "Whether this document is Active or Deprecated within moalmanac-db." } ] } }, "proposition": { "id": 174, "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "biomarkers": [ { "id": 34, "name": "Wild type ALK", "genes": [ { "id": 2, "name": "ALK", "primaryCoding": { "id": "hgnc:427", "code": "HGNC:427", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:427" ] }, "mappings": [ { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000171094", "code": "ENSG00000171094", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000171094" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:238", "code": "238", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/238" ] } }, { "relation": "relatedMatch", "coding": { "id": "refseq:NM_004304.5", "code": "NM_004304.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_004304.5" ] } } ], "extensions": [ { "name": "location", "value": "2p23.2-p23.1" }, { "name": "location_sortable", "value": "02p23.2-p23.1" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] }, { "id": 35, "name": "Wild type EGFR", "genes": [ { "id": 17, "name": "EGFR", "primaryCoding": { "id": "hgnc:3236", "code": "HGNC:3236", "name": null, "system": "https://genenames.org", "systemVersion": null, "iris": [ "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236" ] }, "mappings": [ { "relation": "relatedMatch", "coding": { "id": "refseq:NM_005228.5", "code": "NM_005228.5", "name": null, "system": "https://www.ncbi.nlm.nih.gov/nuccore", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/nuccore/NM_005228.5" ] } }, { "relation": "exactMatch", "coding": { "id": "ensembl:ensg00000146648", "code": "ENSG00000146648", "name": null, "system": "https://www.ensembl.org", "systemVersion": null, "iris": [ "https://www.ensembl.org/id/ENSG00000146648" ] } }, { "relation": "exactMatch", "coding": { "id": "ncbi:1956", "code": "1956", "name": null, "system": "https://www.ncbi.nlm.nih.gov/gene", "systemVersion": null, "iris": [ "https://www.ncbi.nlm.nih.gov/gene/1956" ] } } ], "extensions": [ { "name": "location", "value": "7p11.2" }, { "name": "location_sortable", "value": "07p11.2" } ] } ], "type": "CategoricalVariant", "extensions": [ { "name": "biomarker_type", "value": "Wild type" }, { "name": "present", "value": true } ] } ], "subjectVariant": {}, "conditionQualifier": { "id": 47, "conceptType": "Disease", "name": "Non-Small Cell Lung Cancer", "primaryCoding": { "id": "oncotree:NSCLC", "code": "NSCLC", "name": "Non-Small Cell Lung Cancer", "system": "https://oncotree.mskcc.org", "systemVersion": "oncotree_2021_11_02", "iris": [ "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=NSCLC" ] }, "mappings": [] }, "objectTherapeutic": { "id": 32, "membership_operator": "AND", "therapies": [ { "id": 35, "conceptType": "Drug", "name": "Paclitaxel", "primaryCoding": { "id": "ncit:C1411", "code": "C1411", "name": "Paclitaxel", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1411" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Taxane-based chemotherapy" ], "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" } ] }, { "id": 72, "conceptType": "Drug", "name": "Nivolumab", "primaryCoding": { "id": "ncit:C68814", "code": "C68814", "name": "Nivolumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C68814" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "PD-1/PD-L1 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] }, { "id": 37, "conceptType": "Drug", "name": "Carboplatin", "primaryCoding": { "id": "ncit:C1282", "code": "C1282", "name": "Carboplatin", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1282" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "Platinum-based chemotherapy" ], "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" } ] }, { "id": 71, "conceptType": "Drug", "name": "Ipilimumab", "primaryCoding": { "id": "ncit:C2654", "code": "C2654", "name": "Ipilimumab", "system": "https://evsexplore.semantics.cancer.gov", "systemVersion": "25.01d", "iris": [ "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C2654" ] }, "mappings": [], "extensions": [ { "name": "therapy_strategy", "value": [ "CTLA-4 inhibition" ], "description": "Associated therapeutic strategy or mechanism of action of the therapy." }, { "name": "therapy_type", "value": "Immunotherapy", "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types" } ] } ] } } } ] }