{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema:imfinzi:3 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Aema%3Aimfinzi%3A3",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001532,
    "timestamp_received": "2026-11-09T16:14:18.373025Z",
    "timestamp_returned": "2026-11-09T16:14:18.374557Z",
    "trace_id": "791605aa-2f53-43a4-8979-f4e25aacaa2c"
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  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
  },
  "data": [
    {
      "id": "ind:ema:imfinzi:3",
      "type": "Indication",
      "description": "IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-08-29:5",
          "type": "Contribution",
          "description": "On 2025-06-18, the EMA published an EPAR - Assessment report - Variation that added an extension indication to durvalumab for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.",
          "date": "2025-08-29",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:ema:2025-03-31:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2025-03-31",
          "contributor": {
            "id": "agent:org:ema",
            "type": "Agent",
            "agentType": "organization",
            "name": "European Medicines Agency",
            "description": "Regulatory agency that approves medicines for use in the European Union."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:ema:imfinzi",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Imfinzi (durvalumab) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "AstraZeneca AB. Imfinzi (durvalumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf. Revised July 2025. Accessed August 29, 2025.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/imfinzi"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:ema",
                "type": "Agent",
                "agentType": "organization",
                "name": "European Medicines Agency",
                "description": "Regulatory agency that approves medicines for use in the European Union."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "AstraZeneca AB.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Imfinzi",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "durvalumab",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2018-10-30",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2025-07-11",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": null,
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The European Medicines Agency (EMA) has authorized durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no EGFR mutations or ALK rearrangements. This indication is based on AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial where the choice of platinum-containing chemotherapy was dependent on tumor histology. Specifically, patients with squamous tumor histology received either carboplatin with paclitaxel or cisplatin with gemcitabine, and patients with non-squamous tumor histology received either pemetrexed with carboplatin or pemetrexed with cisplatin.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}