Cabometyx is a cancer medicine used to treat adults with:
- advanced renal cell carcinoma (a 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.
- hepatocellular carcinoma (a liver cancer). It is used on its own in patients who have already been treated with the cancer medicine sorafenib.
Cabometyx contains the active substance cabozantinib.
Cabometyx : EPAR - Medicine overview (PDF/147.48 KB)
First published: 12/10/2016
Last updated: 14/07/2020
|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||
65 Quai Georges Gorse
21/04/2021 Cabometyx - EMEA/H/C/004163 - R/0018
- 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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Renal Cell Carcinoma (RCC)
Cabometyx is indicated as monotherapy 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 202126/02/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018