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    "name": "Molecular Oncology Almanac",
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      "id": "ind:fda:zegfrovy:0",
      "type": "Indication",
      "description": "ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
      "contributions": [
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          "id": "ctrb:vanallenlab:2025-09-03:0",
          "type": "Contribution",
          "description": "The US FDA approved sunvozertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.",
          "date": "2025-09-03",
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          "id": "doc:fda:zegfrovy",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Zegfrovy (sunvozertinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Dizal (Jiangsu) Pharmaceutical Co., Ltd. Zegfrovy (sunvozertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219839s000lbl.pdf. Revised July 2025. Accessed September 3, 2025.",
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              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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              "value": "Zegfrovy",
              "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": "Zegfrovy (sunvozertinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Dizal (Jiangsu) Pharmaceutical Co., Ltd. Zegfrovy (sunvozertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219839s000lbl.pdf. Revised July 2025. Accessed October 6, 2026.",
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          "value": "The U.S. Food and Drug Administration (FDA) granted approval to sunvozertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}