Cabometyx

cabozantinib

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This is a summary of the European public assessment report (EPAR) for Cabometyx. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cabometyx.

For practical information about using Cabometyx, patients should read the package leaflet or contact their doctor or pharmacist.

What is Cabometyx and what is it used for?

Cabometyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer) who have been previously treated with a type of cancer medicine called a ‘vascular endothelial growth factor (VEGF) inhibitor’.

Cabometyx contains the active substance cabozantinib.

How is Cabometyx used?

Cabometyx can only be obtained with a prescription and treatment should be started by a doctor who has experience in using cancer medicines.

Cabometyx is available as tablets (20, 40 and 60 mg). The recommended dose is 60 mg once a day. Patients should not eat for at least two hours before and one hour after their dose of Cabometyx. The dose may need to be reduced or treatment stopped temporarily if serious or intolerable side effects occur. Treatment is continued for as long as the patient benefits from it or until side effects become unacceptable. For further information, see the package leaflet.

How does Cabometyx work?

The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor’. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in certain receptors (such as VEGF, MET, AXL and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer. By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of the cancer.

What benefits of Cabometyx have been shown in studies?

Cabometyx has been investigated in one main study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor. In the study, Cabometyx was compared with the cancer medicine everolimus. Results showed that Cabometyx is effective at prolonging the time patients lived without their disease getting worse (progression-free survival): patients treated with Cabometyx lived for an average of 7.4 months without their disease getting worse compared with 3.8 months in patients treated with everolimus. In addition, preliminary results indicated that patients treated with Cabometyx lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months).

What are the risks associated with Cabometyx?

The most common side effects with Cabometyx (seen in at least 1 in 4 people) are diarrhoea, tiredness, nausea (feeling sick), loss of appetite, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), high blood pressure, vomiting, loss of weight and constipation. The most common serious side effects are abdominal (belly) pain, pleural effusion (build-up of fluid around the lungs), diarrhoea and nausea.

For the full list of all side effects and restrictions with Cabometyx, see the package leaflet.

Why is Cabometyx approved?

Previously treated patients with advanced renal cell carcinoma have poor outcomes and a high unmet medical need. Cabometyx was shown to significantly improve the time these patients lived without their disease getting worse. Early results also indicated that Cabometyx helped patients to live longer. The safety of Cabometyx is similar to other tyrosine kinase inhibitors used in renal cell carcinoma, and side effects are considered manageable. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Cabometyx’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Cabometyx?

The company that markets Cabometyx will provide the final results of the overall survival of patients in the main study.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabometyx have also been included in the summary of product characteristics and the package leaflet.

Other information about Cabometyx

For more information about treatment with Cabometyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Cabometyx : EPAR - Summary for the public BG = bălgarski 2016-10-12  
Cabometyx : EPAR - Summary for the public ES = español 2016-10-12  
Cabometyx : EPAR - Summary for the public CS = čeština 2016-10-12  
Cabometyx : EPAR - Summary for the public DA = dansk 2016-10-12  
Cabometyx : EPAR - Summary for the public DE = Deutsch 2016-10-12  
Cabometyx : EPAR - Summary for the public ET = eesti keel 2016-10-12  
Cabometyx : EPAR - Summary for the public EL = elliniká 2016-10-12  
Cabometyx : EPAR - Summary for the public EN = English 2016-10-12  
Cabometyx : EPAR - Summary for the public FR = français 2016-10-12  
Cabometyx : EPAR - Summary for the public IT = italiano 2016-10-12  
Cabometyx : EPAR - Summary for the public LV = latviešu valoda 2016-10-12  
Cabometyx : EPAR - Summary for the public LT = lietuvių kalba 2016-10-12  
Cabometyx : EPAR - Summary for the public HU = magyar 2016-10-12  
Cabometyx : EPAR - Summary for the public MT = Malti 2016-10-12  
Cabometyx : EPAR - Summary for the public NL = Nederlands 2016-10-12  
Cabometyx : EPAR - Summary for the public PL = polski 2016-10-12  
Cabometyx : EPAR - Summary for the public PT = português 2016-10-12  
Cabometyx : EPAR - Summary for the public RO = română 2016-10-12  
Cabometyx : EPAR - Summary for the public SK = slovenčina 2016-10-12  
Cabometyx : EPAR - Summary for the public SL = slovenščina 2016-10-12  
Cabometyx : EPAR - Summary for the public FI = suomi 2016-10-12  
Cabometyx : EPAR - Summary for the public SV = svenska 2016-10-12  
Cabometyx : EPAR - Summary for the public HR = Hrvatski 2016-10-12  

This EPAR was last updated on 12/10/2016 .

Authorisation details

Product details

Product details for Cabometyx
NameCabometyx
Agency product numberEMEA/H/C/004163
Active substance

cabozantinib s-malate

International non-proprietary name (INN) or common name

cabozantinib

Therapeutic area Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code L01XE26

Publication details

Publication details for Cabometyx
Marketing-authorisation holder

Ipsen Pharma

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/09/2016

Contact address:

Ipsen Pharma
65 Quai Georges Gorse 
92100 Boulogne-Billancourt 
France

Product information

Product information

09/09/2016  Cabometyx -EMEA/H/C/004163 --

Name Language First published Last updated
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - Product Information HR = Hrvatski 2016-10-12  

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  
Cabometyx : EPAR - All Authorised presentations HR = Hrvatski 2016-10-12  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cabometyx : EPAR - Public assessment report HR = Hrvatski 2016-10-12  
CHMP summary of positive opinion for Cabometyx HR = Hrvatski 2016-07-22