{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.talzenna:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.talzenna%3A0",
    "status": "success",
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    "timestamp_elapsed": 0.003702,
    "timestamp_received": "2026-04-24T15:54:49.612420+00:00Z",
    "timestamp_returned": "2026-04-24T15:54:49.616122+00:00Z",
    "trace_id": "4df9e8a9-4e79-469f-b9c4-33bbc49c2bcb"
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  "service": {
    "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.talzenna:0",
      "indication": "TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.",
      "initial_approval_date": "2018-10-16",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to talazoparib for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for Talazoparib.",
      "raw_biomarkers": "deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative",
      "raw_cancer_type": "locally advanced or metastatic breast cancer",
      "raw_therapeutics": "Talzenna (talazoparib)",
      "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.talzenna",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Talzenna (talazoparib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Pfizer, Inc. Talzenna (talazoparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf. Revised February 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211651"
        ],
        "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": "Pfizer, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Talzenna",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "talazoparib",
            "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": 211651,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-02-06",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}