{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=fda&proposition_id=881",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.02976,
    "timestamp_received": "2026-05-15T13:17:23.933442+00:00Z",
    "timestamp_returned": "2026-05-15T13:17:23.963202+00:00Z",
    "trace_id": "569c8b4c-c588-4098-a088-7612e3a2f8ff"
  },
  "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": "2026-05-07"
  },
  "data": [
    {
      "id": 1541,
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
      "contributions": [
        {
          "id": 46,
          "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": "On 2025-11-19, the US FDA granted accelerated approval to Hyrnuo (sevabertinib) for the treatment of patients with NSCLC and activating ERBB2 TKD variants.",
          "date": "2025-12-23"
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda.hyrnuo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Hyrnuo (sevabertinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Bayer HealthCare Pharmaceuticals Inc. Hyrnuo (sevabertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf. Revised November 2025. Accessed December 23, 2025.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972"
          ],
          "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": "2026-05-07",
                    "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": "Bayer HealthCare Pharmaceuticals Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Hyrnuo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "sevabertinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2025-11-19",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 219972,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2025-11-19",
              "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.hyrnuo:0",
        "indication": "HYRNUO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
        "initial_approval_date": "2025-11-19",
        "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf",
        "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
        "raw_biomarkers": "ERBB2 TKD activating variants",
        "raw_cancer_type": "non-small cell lung cancer",
        "raw_therapeutics": "Hyrnuo (sevabertinib)",
        "icd10": null,
        "regimen_code": null,
        "reimbursement_category": null,
        "reimbursement_date": null,
        "reimbursement_details": null,
        "date_regular_approval": null,
        "date_accelerated_approval": "2025-11-19",
        "document": {
          "id": "doc:fda.hyrnuo",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Hyrnuo (sevabertinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Bayer HealthCare Pharmaceuticals Inc. Hyrnuo (sevabertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf. Revised November 2025. Accessed December 23, 2025.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972"
          ],
          "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": "2026-05-07",
                    "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": "Bayer HealthCare Pharmaceuticals Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Hyrnuo",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "sevabertinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2025-11-19",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 219972,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2025-11-19",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      },
      "proposition": {
        "id": 881,
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictSensitivityTo",
        "biomarkers": [
          {
            "id": 173,
            "name": "ERBB2 TKD activating variants",
            "genes": [
              {
                "id": 18,
                "name": "ERBB2",
                "primaryCoding": {
                  "id": "hgnc:3430",
                  "code": "HGNC:3430",
                  "name": null,
                  "system": "https://genenames.org",
                  "systemVersion": null,
                  "iris": [
                    "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3430"
                  ]
                },
                "mappings": [
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ensembl:ensg00000141736",
                      "code": "ENSG00000141736",
                      "name": null,
                      "system": "https://www.ensembl.org",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ensembl.org/id/ENSG00000141736"
                      ]
                    }
                  },
                  {
                    "relation": "exactMatch",
                    "coding": {
                      "id": "ncbi:2064",
                      "code": "2064",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/gene",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/gene/2064"
                      ]
                    }
                  },
                  {
                    "relation": "relatedMatch",
                    "coding": {
                      "id": "refseq:NM_004448.4",
                      "code": "NM_004448.4",
                      "name": null,
                      "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                      "systemVersion": null,
                      "iris": [
                        "https://www.ncbi.nlm.nih.gov/nuccore/NM_004448.4"
                      ]
                    }
                  }
                ],
                "extensions": [
                  {
                    "name": "location",
                    "value": "17q12"
                  },
                  {
                    "name": "location_sortable",
                    "value": "17q12"
                  }
                ]
              }
            ],
            "type": "CategoricalVariant",
            "extensions": [
              {
                "name": "biomarker_type",
                "value": "Somatic Variant"
              },
              {
                "name": "present",
                "value": true
              },
              {
                "name": "chromosome",
                "value": "17"
              },
              {
                "name": "requires_oncogenic",
                "value": true
              }
            ]
          }
        ],
        "subjectVariant": {},
        "conditionQualifier": {
          "id": 89,
          "conceptType": "Disease",
          "name": "Lung Non-Squamous Non-Small Cell Carcinoma",
          "primaryCoding": {
            "id": "ncit:C135017",
            "code": "C135017",
            "name": "Lung Non-Squamous Non-Small Cell Carcinoma",
            "system": "https://evsexplore.semantics.cancer.gov",
            "systemVersion": "25.01d",
            "iris": [
              "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C135017"
            ]
          },
          "mappings": []
        },
        "objectTherapeutic": {
          "id": 161,
          "conceptType": "Drug",
          "name": "Sevabertinib",
          "primaryCoding": {
            "id": "ncit:C185187",
            "code": "C185187",
            "name": null,
            "system": "https://evsexplore.semantics.cancer.gov",
            "systemVersion": "25.01d",
            "iris": [
              "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C185187"
            ]
          },
          "mappings": [
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "rxcui:2728187",
                "code": "2728187",
                "name": "sevabertinib",
                "system": "RxNorm",
                "systemVersion": "02-Mar-2026",
                "iris": [
                  "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2728187"
                ]
              }
            },
            {
              "relation": "relatedMatch",
              "coding": {
                "id": "omop:37354799",
                "code": "37354799",
                "name": "sevabertinib",
                "system": "OMOP",
                "systemVersion": "v20260227",
                "iris": [
                  "https://athena.ohdsi.org/search-terms/terms/37354799"
                ]
              }
            }
          ],
          "extensions": [
            {
              "name": "therapy_strategy",
              "value": [
                "EGFR inhibition",
                "HER2 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"
            }
          ]
        }
      }
    }
  ]
}