{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema.sprycel:3 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.sprycel%3A3",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004018,
    "timestamp_received": "2026-04-24T03:09:09.449362+00:00Z",
    "timestamp_returned": "2026-04-24T03:09:09.453380+00:00Z",
    "trace_id": "5b568149-8aae-4724-be26-243b7c5b68b8"
  },
  "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:ema.sprycel:3",
      "indication": "SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.",
      "initial_approval_date": "2019-03-29",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/sprycel-h-c-709-ii-0059-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized dasatinib (anhydrous) for the treatment of pediatric patients with newly diagnosed Philadelphia acute lymphoblastic leukemia (ALL) in combination with chemotherapy. The product information for this indication further states that his indication is based on a multicenter, historically-controlled phase 2 study that followed the chemotherapy regime detailed in another clinical trial, AIEOP-BFM ALL 2000 (chemotherapeutic standard multi-agent chemotherapy protocol).",
      "raw_biomarkers": null,
      "raw_cancer_type": "Acute lymphoblastic leukemia (ALL)",
      "raw_therapeutics": "Sprycel (dasatinib [anhydrous]) in combination with chemotherapy",
      "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:ema.sprycel",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Sprycel (dasatinib [anhydrous]) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Bristol-Myers Squibb Pharma EEIG. Sprycel (dasatinib [anhydrous]) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf. Revised June 2022. Accessed March 22, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel",
          "https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Bristol-Myers Squibb Pharma EEIG.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Sprycel",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "dasatinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2009-08-18",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2022-06-17",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}