Caprelsa

vandetanib

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This is a summary of the European public assessment report (EPAR) for Caprelsa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Caprelsa.

What is Caprelsa?

Caprelsa is a medicine that contains the active substance vandetanib. It is available as tablets (100 mg and 300 mg).

What is Caprelsa used for?

Caprelsa is used to treat medullary thyroid cancer, a type of cancer affecting the thyroid gland that originates in the cells that produce the hormone calcitonin. It is used when the disease is aggressive and causes symptoms, and when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.

The medicine can only be obtained with a prescription.

How is Caprelsa used?

Treatment should be started and supervised by a doctor who has experience in treating medullary thyroid cancer, using anticancer medicines and assessing electrocardiograms (ECGs, tests that measure the electrical activity of the heart). Patients must be given a patient alert card containing important safety information and must be informed by their doctor about the risks of Caprelsa.

The recommended dose is 300 mg once a day, taken at around the same time each day. Patients who have difficulty swallowing tablets can mix the tablet in still water (no other liquids should be used).

The patient’s QTc interval (a measure of the electrical activity of the heart) and certain blood values should be assessed in advance and monitored during treatment. The doctor should stop treatment if the QTc interval reaches 500 milliseconds or above or if the patient experiences severe side effects, until an improvement is seen, after which treatment may be restarted at a lower dose.

The benefits of Caprelsa may be smaller for patients who do not have a mutation in a gene called the ‘re-arranged during transfection’ (RET) gene or if this is not known, and this should be taken into account when deciding whether to start treatment. For this purpose, it is recommended that the RET mutation status be tested before starting treatment with Caprelsa.

How does Caprelsa work?

The active substance in Caprelsa, vandetanib, is a ‘protein-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, EGF and RET receptors) on the surface of cancer cells, where they activate several processes including cell division and the growth of new blood vessels. By blocking the activity of VEGF receptors, the medicine reduces the blood supply to the cancer cells, slowing down the cancer’s growth. By blocking the activity of EGF receptors, the cancer cells no longer receive the messages needed for growth and multiplication. Vandetanib also blocks the activity of RET receptors, which play a role in the growth of medullary thyroid cancer cells.

How has Caprelsa been studied?

The effects of Caprelsa were first tested in experimental models before being studied in humans.

Caprelsa was compared with placebo (a dummy treatment) in a main study involving 331 patients with thyroid cancer that could not be removed by surgery or had spread to other parts of the body. The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).

What benefit has Caprelsa shown during the studies?

Caprelsa was more effective than placebo at prolonging progression-free survival. On average, patients taking Caprelsa lived for 30.5 months without their disease getting worse, compared with 19.3 months for patients taking placebo.

What is the risk associated with Caprelsa?

The most commonly reported side effects with Caprelsa are diarrhoea, rash, nausea (feeling sick), hypertension (high blood pressure) and headache. For the full list of all side effects reported with Caprelsa, see the package leaflet.

Caprelsa must not be used in people who are hypersensitive (allergic) to vandetanib or any of the other ingredients. It must not be used in people with a heart problem called ‘congenital long QTc syndrome’ or who have a QTc interval over 480 milliseconds. It must not be used in women who are breast-feeding. Caprelsa must not be used in patients who are taking certain other medicines that can prolong the QTc interval. For the full list of restrictions, see the package leaflet.

Why has Caprelsa been approved?

The CHMP concluded that Caprelsa was shown to be effective in the treatment of medullary thyroid cancer although there were uncertainties about the size of the benefit in patients whose RET mutation status is negative or unknown. The Committee noted the potential risk for QTc interval prolongation, and measures were introduced to minimise this risk. The CHMP concluded that the benefits of Caprelsa outweigh its risks in patients whose disease is both aggressive and causes symptoms, since they are in urgent need of treatment. Therefore, the Committee recommended that Caprelsa be granted marketing authorisation.

Caprelsa has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular on the size of the benefit in patients without the RET mutation. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Caprelsa?

The company that markets Caprelsa will carry out a study in patients with medullary thyroid cancer to compare the effects of Caprelsa in patients with and without the RET mutation.

What measures are being taken to ensure the safe use of Caprelsa?

The company that markets Caprelsa will ensure that doctors who are expected to prescribe Caprelsa receive educational material containing important safety information about Caprelsa, including measures to manage the risk of QTc prolongation and other potential side effects, and a patient alert card.

Other information about Caprelsa

The European Commission granted a marketing authorisation valid throughout the European Union for Caprelsa on 17 February 2012.

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

Name Language First published Last updated
Caprelsa : EPAR - Summary for the public BG = bălgarski 02/03/2012  
Caprelsa : EPAR - Summary for the public ES = español 02/03/2012  
Caprelsa : EPAR - Summary for the public CS = čeština 02/03/2012  
Caprelsa : EPAR - Summary for the public DA = dansk 02/03/2012  
Caprelsa : EPAR - Summary for the public DE = Deutsch 02/03/2012  
Caprelsa : EPAR - Summary for the public ET = eesti keel 02/03/2012  
Caprelsa : EPAR - Summary for the public EL = elliniká 02/03/2012  
Caprelsa : EPAR - Summary for the public EN = English 02/03/2012  
Caprelsa : EPAR - Summary for the public FR = français 02/03/2012  
Caprelsa : EPAR - Summary for the public IT = italiano 02/03/2012  
Caprelsa : EPAR - Summary for the public LV = latviešu valoda 02/03/2012  
Caprelsa : EPAR - Summary for the public LT = lietuvių kalba 02/03/2012  
Caprelsa : EPAR - Summary for the public HU = magyar 02/03/2012  
Caprelsa : EPAR - Summary for the public MT = Malti 02/03/2012  
Caprelsa : EPAR - Summary for the public NL = Nederlands 02/03/2012  
Caprelsa : EPAR - Summary for the public PL = polski 02/03/2012  
Caprelsa : EPAR - Summary for the public PT = português 02/03/2012  
Caprelsa : EPAR - Summary for the public RO = română 02/03/2012  
Caprelsa : EPAR - Summary for the public SK = slovenčina 02/03/2012  
Caprelsa : EPAR - Summary for the public SL = slovenščina 02/03/2012  
Caprelsa : EPAR - Summary for the public FI = suomi 02/03/2012  
Caprelsa : EPAR - Summary for the public SV = svenska 02/03/2012  

This EPAR was last updated on 23/01/2014 .

Authorisation details

Product details

Product details for Caprelsa
NameCaprelsa
Agency product numberEMEA/H/C/002315
Active substance

vandetanib

International non-proprietary name (INN) or common name

vandetanib

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.

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 Caprelsa
Marketing-authorisation holder

AstraZeneca AB

Revision2
Date of issue of marketing authorisation valid throughout the European Union17/02/2012

Contact address:

AstraZeneca AB
S-151 85 Södertälje
Sweden

Product information

Product information

20/12/2013  Caprelsa -EMEA/H/C/002315 -R/0005

Name Language First published Last updated
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014
Caprelsa : EPAR - Product Information SV = svenska 02/03/2012 23/01/2014

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
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  
Caprelsa : EPAR - All Authorised presentations SV = svenska 02/03/2012  

Name Language First published Last updated
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  
Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/03/2012  

Pharmacotherapeutic group

Antineoplastic and immunomodulating agents

Therapeutic indication

Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Caprelsa : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 28/02/2013 23/01/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Caprelsa : EPAR - Public assessment report SV = svenska 02/03/2012  
CHMP summary of positive opinion for Caprelsa SV = svenska 18/11/2011  

Authorised

This medicine is approved for use in the European Union