{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda:mekinist:5 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Afda%3Amekinist%3A5",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001579,
    "timestamp_received": "2026-11-09T16:14:27.482349Z",
    "timestamp_returned": "2026-11-09T16:14:27.483928Z",
    "trace_id": "b424bb1a-4de4-405c-a728-df816f956f71"
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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:fda:mekinist:5",
      "type": "Indication",
      "description": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:mekinist",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Mekinist (trametinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Novartis Pharmaceuticals Corporation. Mekinist (trametinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf. Revised March 2024. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217513"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Novartis Pharmaceuticals Corporation.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Mekinist",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "trametinib",
              "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": "publication_date",
              "value": "2024-03-29",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "NDA217513",
              "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."
            }
          ]
        },
        {
          "id": "doc:fda:mekinist:2022-06-22",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Mekinist (trametinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Novartis Pharmaceuticals Corporation. Mekinist (trametinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s024lbl.pdf. Revised June 2022. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s024lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204114"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Novartis Pharmaceuticals Corporation.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Mekinist",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "trametinib",
              "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": "publication_date",
              "value": "2022-06-22",
              "description": "The publication date for the document."
            },
            {
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              "value": "NDA204114",
              "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": "Deprecated",
              "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 U.S. Food and Drug Administration granted accelerated approval to trametinib in combination with dabrafenib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. The product label specifies that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, the product label states a Limitation of Use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}