{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.akeega:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.akeega%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004321,
    "timestamp_received": "2026-04-24T07:54:22.367435+00:00Z",
    "timestamp_returned": "2026-04-24T07:54:22.371756+00:00Z",
    "trace_id": "b2607b4e-f3af-41fd-844d-36307cc4383c"
  },
  "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.akeega:0",
      "indication": "AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA.",
      "initial_approval_date": "2023-08-11",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted approval to Akeega (abiraterone acetate with niraparib) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for Akeega.",
      "raw_biomarkers": "deleterious or suspected deleterious BRCA-mutated (BRCAm)",
      "raw_cancer_type": "metastatic castration-resistant prostate cancer",
      "raw_therapeutics": "Akeega (abiraterone acetate and niraparib) in combination with prednisone",
      "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.akeega",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Akeega (abiraterone acetate and niraparib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Janssen Biotech, Inc. Akeega (abiraterone acetate and niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf. Revised December 2025. Accessed February 5, 2026.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216793"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "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": "Janssen Biotech, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Akeega",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "abiraterone acetate and niraparib",
            "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": 216793,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-12-12",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}