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      "description": "The U.S. Food and Drug Administration granted approval to durvalumab in combination with tremelimumab-actl and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, and multicenter study where patients received one of the following chemotherapy regimes: pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.",
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                        "primaryCoding": {
                          "id": "coding:hgnc:3236",
                          "code": "HGNC:3236",
                          "system": "https://genenames.org",
                          "iris": [
                            "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:3236"
                          ]
                        },
                        "mappings": [
                          {
                            "relation": "exactMatch",
                            "coding": {
                              "id": "coding:ensembl:ensg00000146648",
                              "code": "ENSG00000146648",
                              "system": "https://www.ensembl.org",
                              "iris": [
                                "https://www.ensembl.org/id/ENSG00000146648"
                              ]
                            }
                          },
                          {
                            "relation": "exactMatch",
                            "coding": {
                              "id": "coding:ncbi:1956",
                              "code": "1956",
                              "system": "https://www.ncbi.nlm.nih.gov/gene",
                              "iris": [
                                "https://www.ncbi.nlm.nih.gov/gene/1956"
                              ]
                            }
                          },
                          {
                            "relation": "relatedMatch",
                            "coding": {
                              "id": "coding:refseq:NM_005228.5",
                              "code": "NM_005228.5",
                              "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                              "iris": [
                                "https://www.ncbi.nlm.nih.gov/nuccore/NM_005228.5"
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ],
                  "extensions": [
                    {
                      "name": "biomarker_type",
                      "value": "Wild type"
                    }
                  ]
                }
              }
            ],
            "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:imjudo:0",
            "type": "Indication",
            "description": "IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.",
            "contributions": [
              {
                "id": "ctrb:vanallenlab:2025-01-10:0",
                "type": "Contribution",
                "description": "Additional FDA approvals for initial version",
                "date": "2025-01-10",
                "contributor": {
                  "id": "agent:user:vanallenlab",
                  "type": "Agent",
                  "agentType": "contributor",
                  "name": "Van Allen lab",
                  "description": "Van Allen lab, Dana-Farber Cancer Institute"
                }
              },
              {
                "id": "ctrb:fda:2022-11-10:0",
                "type": "Contribution",
                "description": "Indication received traditional approval.",
                "date": "2022-11-10",
                "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:imjudo",
                "type": "Document",
                "documentType": "Regulatory approval",
                "name": "Imjudo (tremelimumab-actl) [package insert]. FDA.",
                "title": null,
                "aliases": [],
                "description": "AstraZeneca AB. Imjudo (tremelimumab-actl) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Revised November 2022. Accessed October 30, 2024.",
                "urls": [
                  "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf",
                  "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761270"
                ],
                "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": "AstraZeneca AB.",
                    "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_brand",
                    "value": "Imjudo",
                    "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_generic",
                    "value": "tremelimumab-actl",
                    "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": 761270,
                    "description": "Identification number used by the publishing organization."
                  },
                  {
                    "name": "publication_date",
                    "value": "2022-11-10",
                    "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."
        }
      ]
    }
  ]
}