Cabometyx

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cabozantinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.
  • differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland). Cabometyx is used after systemic therapy (affecting the whole body) when the cancer has progressed or spread locally or to other parts of the body. It is used when the cancer does not respond to treatment with radioactive iodine or in patients who cannot have radioactive iodine.

Cabometyx contains the active substance cabozantinib.

This EPAR was last updated on 09/06/2022

Authorisation details

Product details
Name
Cabometyx
Agency product number
EMEA/H/C/004163
Active substance
cabozantinib (s)-malate
International non-proprietary name (INN) or common name
cabozantinib
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Carcinomas, Hepatocellular
Anatomical therapeutic chemical (ATC) code
L01EX07
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
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
09/09/2016
Contact address
65 Quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

29/04/2022 Cabometyx - EMEA/H/C/004163 - II/0023

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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