Cometriq

cabozantinib

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This is a summary of the European public assessment report (EPAR) for Cometriq. 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 Cometriq.

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

What is Cometriq and what is it used for?

Cometriq is a cancer medicine that contains the active substance cabozantinib. It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin. Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.

The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection’ (RET) gene, and this should be taken into account when deciding whether to start treatment.

Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare’, and Cometriq was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 February 2009.

How is Cometriq used?

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

Cometriq is available as capsules (20 and 80 mg). The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules. Patients should not eat for at least two hours before and one hour after their dose of Cometriq. The dose may need to be reduced or stopped temporarily due to side effects, especially during the first eight weeks of therapy. Treatment is continued until the patient no longer benefits from it or side effects become unacceptable.

Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body. For further information, see the package leaflet.

How does Cometriq work?

The active substance in Cometriq, cabozantinib, is a receptor-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 and RET receptors) on the surface of cells, including 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 receptors in cancer cells, the medicine reduces the growth and spread of the cancer.

What benefits of Cometriq have been shown in studies?

Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body. Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment). The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq this was 11.2 months , compared with 4 months in those given placebo.

What are the risks associated with Cometriq?

The most common side effects with Cometriq (which may affect more than 2 in 10 people) are diarrhoea, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), loss of weight, loss of appetite, nausea (feeling sick), tiredness, taste disturbances, changes in hair colour, hypertension (high blood pressure), inflammation of the mucosa (moist tissue that lines certain body cavities) including stomatitis (inflammation of the lining of the mouth), constipation, vomiting, weakness, and changes in the sound of the voice. The most common abnormal results in laboratory blood tests were increased liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP), low white cell counts (lymphopenia or neutropenia), thrombocytopenia (low blood-platelet counts), hypocalcaemia (low blood-calcium levels), hypophosphatemia (low phosphate), hypoalbuminaemia (low amounts of the protein albumin), and hyperbilirubinaemia (increased amounts of bilirubin, a breakdown product of red blood cells).

The most common serious side effects are pneumonia, inflammation of the mucosa, hypocalcaemia (low calcium levels in the blood), dysphagia (difficulty swallowing), dehydration, pulmonary embolism (blood clots in the vessels supplying the lungs), and hypertension. For the full list of all side effects and restrictions with Cometriq, see the package leaflet.

Why is Cometriq approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq’s benefits are greater than its risks and recommended that it be approved for use in the EU. Cometriq had shown a benefit in patients with advanced medullary thyroid cancer unsuitable for surgery, who have few other treatment options. The side effects were considered manageable and were acceptable, compared with the limited other treatment options available. However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects.

Cometriq has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Cometriq?

Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.

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

A risk management plan has been developed to ensure that Cometriq is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Cometriq

The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014.

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

Name Language First published Last updated
Cometriq : EPAR - Summary for the public BG = bălgarski 26/03/2014  
Cometriq : EPAR - Summary for the public ES = español 26/03/2014  
Cometriq : EPAR - Summary for the public CS = čeština 26/03/2014  
Cometriq : EPAR - Summary for the public DA = dansk 26/03/2014  
Cometriq : EPAR - Summary for the public DE = Deutsch 26/03/2014  
Cometriq : EPAR - Summary for the public ET = eesti keel 26/03/2014  
Cometriq : EPAR - Summary for the public EL = elliniká 26/03/2014  
Cometriq : EPAR - Summary for the public EN = English 26/03/2014  
Cometriq : EPAR - Summary for the public FR = français 26/03/2014  
Cometriq : EPAR - Summary for the public IT = italiano 26/03/2014  
Cometriq : EPAR - Summary for the public LV = latviešu valoda 26/03/2014  
Cometriq : EPAR - Summary for the public LT = lietuvių kalba 26/03/2014  
Cometriq : EPAR - Summary for the public HU = magyar 26/03/2014  
Cometriq : EPAR - Summary for the public MT = Malti 26/03/2014  
Cometriq : EPAR - Summary for the public NL = Nederlands 26/03/2014  
Cometriq : EPAR - Summary for the public PL = polski 26/03/2014  
Cometriq : EPAR - Summary for the public PT = português 26/03/2014  
Cometriq : EPAR - Summary for the public RO = română 26/03/2014  
Cometriq : EPAR - Summary for the public SK = slovenčina 26/03/2014  
Cometriq : EPAR - Summary for the public SL = slovenščina 26/03/2014  
Cometriq : EPAR - Summary for the public FI = suomi 26/03/2014  
Cometriq : EPAR - Summary for the public SV = svenska 26/03/2014  
Cometriq : EPAR - Summary for the public HR = Hrvatski 26/03/2014  
Name Language First published Last updated
Cometriq : EPAR - Risk-management-plan summary (English only) 26/03/2014 13/05/2014

This EPAR was last updated on 11/11/2014 .

Authorisation details

Product details

Product details for Cometriq
NameCometriq
Agency product numberEMEA/H/C/002640
Active substance

cabozantinib

International non-proprietary name (INN) or common name

cabozantinib

Therapeutic area Thyroid Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE
Additional monitoring

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

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Cometriq
Marketing-authorisation holder

TMC Pharma Services Ltd

Revision2
Date of issue of marketing authorisation valid throughout the European Union21/03/2014

Contact address:

TMC Pharma Services Ltd
Lodge Farm Barn, Elvetham Park Estate
Fleet Road, Hartley Wintney
Hampshire RG27 8AS
United Kingdom

Product information

Product information

25/09/2014  Cometriq -EMEA/H/C/002640 -II/0004/G

Name Language First published Last updated
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014
Cometriq : EPAR - Product Information EN = English 26/03/2014 11/11/2014

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
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  
Cometriq : EPAR - All Authorised presentations EN = English 26/03/2014  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Cometriq : EPAR - Procedural steps taken and scientific information after authorisation EN = English 14/08/2014 11/11/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Cometriq : EPAR - Public assessment report EN = English 26/03/2014  
CHMP summary of positive opinion for Cometriq EN = English 20/12/2013  

Authorised

This medicine is approved for use in the European Union

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