Zaltrap

aflibercept

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

What is Zaltrap?

Zaltrap is a medicine that contains the active substance aflibercept. It is available as a concentrate to be made into a solution for infusion (drip) into a vein.

What is Zaltrap used for?

Zaltrap is used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body) for whom treatment based on another medicine, oxaliplatin, has not worked or the cancer got worse. Zaltrap is used with FOLFIRI, which is a treatment combining the medicines irinotecan, 5-fluorouracil, and folinic acid.

The medicine can only be obtained with a prescription.

How is Zaltrap used?

Treatment with Zaltrap should be supervised by a doctor who is experienced in using anticancer medicines.

Zaltrap is given as an infusion into the vein over one hour, at a dose of 4 mg per kilogram body weight. This is then followed by the FOLFIRI treatment. This cycle of treatment is repeated every two weeks, until the disease gets worse or the patient cannot tolerate the treatment. Treatment should be discontinued, delayed, or the dose may have to be adjusted, in patients who develop certain side effects.

How does Zaltrap work?

The active substance in Zaltrap, aflibercept, is a protein that binds to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and makes blood vessels grow. By binding to VEGF and PlGF, aflibercept stops them having an effect. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.

How has Zaltrap been studied?

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

Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment. Zaltrap was compared with placebo (a dummy treatment) when added to FOLFIRI. The main measure of effectiveness was the average length of time that patients survived after treatment.

What benefit has Zaltrap shown during the studies?

Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.

What is the risk associated with Zaltrap?

The most common side effects with Zaltrap (seen in more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), fatigue, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache. The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, fatigue, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).

For the full list of all side effects reported with Zaltrap, see the package leaflet.

Zaltrap must not be used in people who are hypersensitive (allergic) to aflibercept or any of the other ingredients. Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.

Why has Zaltrap been approved?

Although Zaltrap is associated with significant side effects, which can be severe enough to force treatment to be stopped, the results of the large main study show that there is a small but clinically significant benefit in prolonging the life of treated patients in whom previous treatment failed. Overall, the CHMP decided that Zaltrap’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What information is still awaited for Zaltrap?

The company that makes Zaltrap will analyse the blood and tissue of patients involved in the clinical-trial programmes. This is to try to identify those patients who are more likely to respond to treatment.

Other information about Zaltrap

The European Commission granted a marketing authorisation valid throughout the European Union for Zaltrap on 1 February 2013.

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

Name Language First published Last updated
Zaltrap : EPAR - Summary for the public BG = bălgarski 07/03/2013  
Zaltrap : EPAR - Summary for the public ES = español 07/03/2013  
Zaltrap : EPAR - Summary for the public CS = čeština 07/03/2013  
Zaltrap : EPAR - Summary for the public DA = dansk 07/03/2013  
Zaltrap : EPAR - Summary for the public DE = Deutsch 07/03/2013  
Zaltrap : EPAR - Summary for the public ET = eesti keel 07/03/2013  
Zaltrap : EPAR - Summary for the public EL = elliniká 07/03/2013  
Zaltrap : EPAR - Summary for the public EN = English 07/03/2013  
Zaltrap : EPAR - Summary for the public FR = français 07/03/2013  
Zaltrap : EPAR - Summary for the public IT = italiano 07/03/2013  
Zaltrap : EPAR - Summary for the public LV = latviešu valoda 07/03/2013  
Zaltrap : EPAR - Summary for the public LT = lietuvių kalba 07/03/2013  
Zaltrap : EPAR - Summary for the public HU = magyar 07/03/2013  
Zaltrap : EPAR - Summary for the public MT = Malti 07/03/2013  
Zaltrap : EPAR - Summary for the public NL = Nederlands 07/03/2013  
Zaltrap : EPAR - Summary for the public PL = polski 07/03/2013  
Zaltrap : EPAR - Summary for the public PT = português 07/03/2013  
Zaltrap : EPAR - Summary for the public RO = română 07/03/2013  
Zaltrap : EPAR - Summary for the public SK = slovenčina 07/03/2013  
Zaltrap : EPAR - Summary for the public SL = slovenščina 07/03/2013  
Zaltrap : EPAR - Summary for the public FI = suomi 07/03/2013  
Zaltrap : EPAR - Summary for the public SV = svenska 07/03/2013  

This EPAR was last updated on 04/12/2014 .

Authorisation details

Product details

Product details for Zaltrap
NameZaltrap
Agency product numberEMEA/H/C/002532
Active substance

aflibercept

International non-proprietary name (INN) or common name

aflibercept

Therapeutic area Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX44
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.

Publication details

Publication details for Zaltrap
Marketing-authorisation holder

Sanofi-Aventis Groupe

Revision2
Date of issue of marketing authorisation valid throughout the European Union01/02/2013

Contact address:

Sanofi-Aventis Groupe
54 rue La Boétie
F-75008 Paris
France

Product information

Product information

19/11/2014  Zaltrap -EMEA/H/C/002532 -PSUV/0009

Name Language First published Last updated
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014
Zaltrap : EPAR - Product Information SV = svenska 07/03/2013 04/12/2014

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
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  
Zaltrap : EPAR - All Authorised presentations SV = svenska 07/03/2013  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of metastatic colorectal cancer (MCRC).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zaltrap : EPAR - Public assessment report SV = svenska 07/03/2013  
CHMP summary of positive opinion for Zaltrap SV = svenska 16/11/2012  

Authorised

This medicine is approved for use in the European Union