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    "timestamp_received": "2026-04-24T15:54:20.996361+00:00Z",
    "timestamp_returned": "2026-04-24T15:54:21.000269+00:00Z",
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.tagrisso:2",
      "indication": "TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.",
      "initial_approval_date": "2024-02-16",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s030lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This indication is based on FLAURA2 (NCT04035486), a randomized, multicenter, and open-label trial where patients were randomized to receive either osimertinib or osimertinib in combination with pemetrexed and investigator's choice of either cisplatin or carboplatin.",
      "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R mutations",
      "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer",
      "raw_therapeutics": "Tagrisso (osimertinib) in combination with pemetrexed and 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:fda.tagrisso",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tagrisso (osimertinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf. Revised September 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065"
        ],
        "doi": null,
        "pmid": null,
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              "agentType": "organization",
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              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
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                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
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              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "AstraZeneca Pharmaceuticals, LP.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tagrisso",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "osimertinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2015-11-13",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 208065,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-09-25",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}