{
  "meta": {
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    "message": "Indication id ind:fda.krazati:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.krazati%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003882,
    "timestamp_received": "2026-04-24T17:03:48.873998+00:00Z",
    "timestamp_returned": "2026-04-24T17:03:48.877880+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.krazati:0",
      "indication": "KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).",
      "initial_approval_date": "2022-12-12",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to adagrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR), and that continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "KRAS G12C",
      "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer",
      "raw_therapeutics": "Krazati (adagrasib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2022-12-20",
      "document": {
        "id": "doc:fda.krazati",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Krazati (adagrasib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Mirati Therapeutics, Inc. Krazati (adagrasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf. Revised December 2022. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=216340"
        ],
        "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": "Mirati Therapeutics, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Krazati",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "adagrasib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2022-12-12",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 216340,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2022-12-12",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}