欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cabometyx
适用类别Human
治疗领域Carcinoma, Renal Cell;Carcinomas, Hepatocellular
通用名/非专利名称cabozantinib
活性成分cabozantinib (s)-malate
产品号EMEA/H/C/004163
患者安全信息No
许可状态Authorised
ATC编码L01EX07
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评Yes
是否罕用药No
上市许可日期2016/09/09
上市许可开发者/申请人/持有人Ipsen Pharma
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2016/07/21
欧盟委员会决定日期2025/10/24
修订号20
治疗适应症Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
适用物种
兽用药物ATC编码
首次发布日期2018/05/08
最后更新日期2025/10/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cabometyx
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