{
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    "message": "Indication id ind:fda.exkivity:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.exkivity%3A0",
    "status": "success",
    "status_code": 200,
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    "timestamp_received": "2026-04-24T16:01:20.302362+00:00Z",
    "timestamp_returned": "2026-04-24T16:01:20.305931+00:00Z",
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
  },
  "data": [
    {
      "id": "ind:fda.exkivity:0",
      "indication": "EXKIVITY 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).",
      "initial_approval_date": "2021-09-15",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215310s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to mobocertinib 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. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
      "raw_biomarkers": "EGFR exon 20 insertion mutations",
      "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer",
      "raw_therapeutics": "Exkivity (mobocertinib)",
      "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.exkivity",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Exkivity (mobocertinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Takeda Pharmaceuticals America, Inc. Exkivity (mobocertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215310s003lbl.pdf. Revised September 2023. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215310s003lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "value": {
              "id": "fda",
              "type": "Agent",
              "agentType": "organization",
              "name": "Food and Drug Administration",
              "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": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Takeda Pharmaceuticals America, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Exkivity",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "mobocertinib",
            "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": 215310,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2023-09-15",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}