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    "name": "Molecular Oncology Almanac",
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  "data": [
    {
      "id": "ind:fda:tagrisso:2",
      "type": "Indication",
      "description": "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.",
      "contributions": [
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          "date": "2024-10-30",
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            "description": "Van Allen lab, Dana-Farber Cancer Institute"
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        {
          "id": "ctrb:fda:2024-02-16:0",
          "type": "Contribution",
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          "date": "2024-02-16",
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          "id": "doc:fda:tagrisso",
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          "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": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065"
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              "value": "Tagrisso",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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          "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/2024/208065s030lbl.pdf. Revised February 2024. Accessed October 6, 2026.",
          "urls": [
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          "value": "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.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}