An overview of Cabometyx and why it is authorised in the EU
Cabometyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer). It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor’. It is also used in patients who have not had previous treatment and whose cancer is at moderate or high risk of rapidly getting worse.
Cabometyx contains the active substance cabozantinib.
Cabometyx : EPAR - Medicine overview (PDF/77.94 KB)
First published: 12/10/2016
Last updated: 07/06/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Renal Cell
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
07/05/2018 Cabometyx - EMEA/H/C/004163 - II/0003
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC):
- in treatment-naïve adults with intermediate or poor risk,
- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018