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.

Cabometyx contains the active substance cabozantinib.

This EPAR was last updated on 16/10/2019

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
Anatomical therapeutic chemical (ATC) code
L01XE26
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.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Ipsen Pharma
Revision
5
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

19/08/2019 Cabometyx - EMEA/H/C/004163 - IAIN/0009/G

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Renal Cell Carcinoma (RCC)

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

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

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