{
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    "message": "Indication id ind:fda.tarceva:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.tarceva%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003724,
    "timestamp_received": "2026-04-24T20:03:43.840784+00:00Z",
    "timestamp_returned": "2026-04-24T20:03:43.844508+00:00Z",
    "trace_id": "4e3d2151-1da5-4111-b9bd-f36fe48907de"
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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.tarceva:0",
      "indication": "TARCEVA is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. TARCEVA is not recommended for use in combination with platinum-based chemotherapy.",
      "initial_approval_date": "2016-10-18",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to erlotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotnib's product label further states that safety and efficacy of erlotnib have not been established in patients with NSCLC whose tumors have other EGFR mutations. Furthermore, the product label states that it is not recommended for use in combination with platinum-based chemotherapy.",
      "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R",
      "raw_cancer_type": "metastatic non-small cell lung cancer",
      "raw_therapeutics": "Tarceva (erlotinib)",
      "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.tarceva",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tarceva (erlotinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "OSI Pharmaceuticals, LLC. Tarceva (erlotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf. Revised October 2016. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021743"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "name": "agent",
            "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": ""
                },
                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "OSI Pharmaceuticals, LLC.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tarceva",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "erlotinib",
            "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": 21743,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2016-10-18",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}