{
  "meta": {
    "data_length": 1,
    "message": "Statement id stmt:hc:tykerb:0:0 retrieved successfully",
    "request_url": "https://api.moalmanac.org/statements?statement_id=stmt%3Ahc%3Atykerb%3A0%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.002281,
    "timestamp_received": "2026-10-17T00:33:29.808206+00:00Z",
    "timestamp_returned": "2026-10-17T00:33:29.810487+00:00Z",
    "trace_id": "0f7be49c-1e70-45a2-9d8d-5e0f6a539c69"
  },
  "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:hc:tykerb:0:0",
      "type": "Statement",
      "description": "Health Canada approved lapatinib in combination with capecitabine, for the treatment of patients with metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressed on taxanes and anthracycline before starting this therapy. In addition, patients should have progressed on prior trastuzumab therapy in the metastatic setting.",
      "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"
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:hc:tykerb",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Tykerb (lapatinib) [product monograph]. HC.",
          "title": null,
          "aliases": [],
          "description": "Novartis Pharmaceuticals Canada Inc. Tykerb (lapatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00064944.PDF. Revised March 2022. Accessed June 2025.",
          "urls": [
            "https://pdf.hres.ca/dpd_pm/00064944.PDF",
            "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81179"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:hc",
                "type": "Agent",
                "agentType": "organization",
                "name": "Health Canada",
                "description": "Regulatory agency that approves drugs for sale and use in Canada."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Novartis Pharmaceuticals Canada Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Tykerb",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "lapatinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2009-01-05",
              "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": "2022-03-02",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "direction": "supports",
      "proposition": {
        "id": "prop:vtxr:195",
        "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: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:34",
          "membershipOperator": "AND",
          "therapies": [
            {
              "id": "tx:ncit:C1794",
              "conceptType": "Therapy",
              "name": "Capecitabine",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:194000",
                    "code": "194000",
                    "name": "capecitabine",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=194000"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1337620",
                    "code": "1337620",
                    "name": "capecitabine",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1337620"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Thymidylate synthase inhibition"
                  ],
                  "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:C1794",
                "code": "C1794",
                "name": "Capecitabine",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "26.08e",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1794"
                ]
              }
            },
            {
              "id": "tx:ncit:C26653",
              "conceptType": "Therapy",
              "name": "Lapatinib",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:480167",
                    "code": "480167",
                    "name": "lapatinib",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=480167"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1359548",
                    "code": "1359548",
                    "name": "lapatinib",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1359548"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "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"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C26653",
                "code": "C26653",
                "name": "Lapatinib",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "26.08e",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C26653"
                ]
              }
            }
          ]
        },
        "extensions": [
          {
            "name": "biomarkers",
            "value": [
              {
                "id": "bmkr.criterion:20",
                "present": true,
                "subject": {
                  "id": "bmkr:20",
                  "type": "CategoricalVariant",
                  "name": "HER2-positive",
                  "constraints": [],
                  "extensions": [
                    {
                      "name": "biomarker_type",
                      "value": "Protein expression"
                    },
                    {
                      "name": "marker",
                      "value": "Human epidermal growth factor receptor 2 (HER2)"
                    },
                    {
                      "name": "unit",
                      "value": "status"
                    },
                    {
                      "name": "equality",
                      "value": "="
                    },
                    {
                      "name": "value",
                      "value": "Positive"
                    }
                  ]
                }
              }
            ],
            "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": "26.08e",
          "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:hc:tykerb:0",
            "type": "Indication",
            "description": "TYKERB (lapatinib tablets) is indicated for in combination with capecitabine, for the treatment of patients with metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressed on taxanes and anthracycline before starting this therapy. In addition, patients should have progressed on prior trastuzumab therapy in the metastatic setting.",
            "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"
                }
              }
            ],
            "reportedIn": [
              {
                "id": "doc:hc:tykerb",
                "type": "Document",
                "documentType": "Regulatory approval",
                "name": "Tykerb (lapatinib) [product monograph]. HC.",
                "title": null,
                "aliases": [],
                "description": "Novartis Pharmaceuticals Canada Inc. Tykerb (lapatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00064944.PDF. Revised March 2022. Accessed June 2025.",
                "urls": [
                  "https://pdf.hres.ca/dpd_pm/00064944.PDF",
                  "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81179"
                ],
                "doi": null,
                "pmid": null,
                "extensions": [
                  {
                    "name": "agent",
                    "value": {
                      "id": "agent:org:hc",
                      "type": "Agent",
                      "agentType": "organization",
                      "name": "Health Canada",
                      "description": "Regulatory agency that approves drugs for sale and use in Canada."
                    },
                    "description": "The organization that published this document."
                  },
                  {
                    "name": "company",
                    "value": "Novartis Pharmaceuticals Canada Inc.",
                    "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_brand",
                    "value": "Tykerb",
                    "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_generic",
                    "value": "lapatinib",
                    "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "first_publication_date",
                    "value": "2009-01-05",
                    "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": "2022-03-02",
                    "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."
        }
      ]
    }
  ]
}