{
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    "message": "Indication id ind:fda.opdivo:2 retrieved successfully",
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    "timestamp_received": "2026-04-06T14:45:49.217894+00:00Z",
    "timestamp_returned": "2026-04-06T14:45:49.221697+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": "2026-03-05"
  },
  "data": [
    {
      "id": "ind:fda.opdivo:2",
      "indication": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.",
      "initial_approval_date": "2020-05-26",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s082lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.",
      "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations",
      "raw_cancer_type": "non-small cell lung cancer",
      "raw_therapeutics": "nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": "2025-05-26",
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:fda.opdivo",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Opdivo (nivolumab) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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              "type": "Agent",
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              "extensions": [
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                  "name": "last_updated",
                  "value": "2026-03-02",
                  "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": "Bristol-Myers Squibb Company.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Opdivo",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "nivolumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2014-12-22",
            "description": "The publication date for the initial version of this document."
          },
          {
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            "value": 125554,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-04-11",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}