This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 05/05/2021

Authorisation details

Product details
Agency product number
Active substance
cabozantinib (s)-malate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Carcinomas, Hepatocellular
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
Ipsen Pharma
Date of issue of marketing authorisation valid throughout the European Union
Contact address
65 Quai Georges Gorse
92100 Boulogne-Billancourt

Product information

21/04/2021 Cabometyx - EMEA/H/C/004163 - R/0018


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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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