Halaven

eribulin

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

What is Halaven?

Halaven is a solution for injection that contains the active substance eribulin.

What is Halaven used for?

Halaven is used on its own to treat locally advanced or metastatic breast cancer that has continued to spread after at least two other treatments for advanced cancer. Previous treatment should include an anthracycline and a taxane unless these treatments were not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body.

The medicine can only be obtained with a prescription.

How is Halaven used?

Halaven treatment should be given in specialised cancer units under the supervision of a doctor experienced in the use of anticancer medicines.

Halaven is given as intravenous injections over 21‑day cycles. The dose to be given is calculated using the patient’s body surface area (calculated using the patient’s height and weight). The recommended dose is 1.23 mg/m2 given into a vein over two to five minutes on days 1 and 8 of each cycle. Doctors should consider giving patients an anti-emetic (a medicine that prevents nausea and vomiting) as Halaven may cause nausea or vomiting.

Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired. For more details on the use of Halaven, including recommendations on dose reduction, see the summary of product characteristics (also part of the EPAR).

How does Halaven work?

The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai. It attaches to a protein in cells called ‘tubulin’, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide. By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.

How has Halaven been studied?

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

In a main study, Halaven was compared with other treatments in 762 women with advanced or metastatic breast cancer, who had previously undergone at least two other treatments, which included an anthracycline and a taxane. The women were given either Halaven or another approved anticancer medicine chosen by their doctor. The main measure of effectiveness was overall survival (how long the patients lived).

What benefit has Halaven shown during the studies?

When comparing Halaven with all the other treatments grouped together, Halaven was shown to be more effective at prolonging life. Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.

What is the risk associated with Halaven?

The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white-blood-cell counts), anaemia (low red-blood-cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain, fatigue (tiredness) and pyrexia (fever). For the full list of all side effects reported with Halaven, see the package leaflet.

Halaven should not be used in people who may be hypersensitive (allergic) to eribulin or any of the other ingredients. It must not be used in women who are breastfeeding.

Why has Halaven been approved?

The CHMP noted that, in addition to its effect on survival, Halaven also prolonged the length of time that patients lived without their disease getting worse (progression-free survival). The CHMP decided that Halaven’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Halaven

The European Commission granted a marketing authorisation valid throughout the European Union for Halaven to Eisai Europe Ltd on 17 March 2011. The marketing authorisation is valid for five years, after which it can be renewed.

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

Name Language First published Last updated
Halaven : EPAR - Summary for the public BG = bălgarski 11/04/2011  
Halaven : EPAR - Summary for the public ES = español 11/04/2011  
Halaven : EPAR - Summary for the public CS = čeština 11/04/2011  
Halaven : EPAR - Summary for the public DA = dansk 11/04/2011  
Halaven : EPAR - Summary for the public DE = Deutsch 11/04/2011  
Halaven : EPAR - Summary for the public ET = eesti keel 11/04/2011  
Halaven : EPAR - Summary for the public EL = elliniká 11/04/2011  
Halaven : EPAR - Summary for the public EN = English 11/04/2011  
Halaven : EPAR - Summary for the public FR = français 11/04/2011  
Halaven : EPAR - Summary for the public IT = italiano 11/04/2011  
Halaven : EPAR - Summary for the public LV = latviešu valoda 11/04/2011  
Halaven : EPAR - Summary for the public LT = lietuvių kalba 11/04/2011  
Halaven : EPAR - Summary for the public HU = magyar 11/04/2011  
Halaven : EPAR - Summary for the public MT = Malti 11/04/2011  
Halaven : EPAR - Summary for the public NL = Nederlands 11/04/2011  
Halaven : EPAR - Summary for the public PL = polski 11/04/2011  
Halaven : EPAR - Summary for the public PT = português 11/04/2011  
Halaven : EPAR - Summary for the public RO = română 11/04/2011  
Halaven : EPAR - Summary for the public SK = slovenčina 11/04/2011  
Halaven : EPAR - Summary for the public SL = slovenščina 11/04/2011  
Halaven : EPAR - Summary for the public FI = suomi 11/04/2011  
Halaven : EPAR - Summary for the public SV = svenska 11/04/2011  

This EPAR was last updated on 07/02/2014 .

Authorisation details

Product details

Product details for Halaven
NameHalaven
Agency product numberEMEA/H/C/002084
Active substance

eribulin

International non-proprietary name (INN) or common name

eribulin

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX41
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 Halaven
Marketing-authorisation holder

Eisai Europe Ltd.

Revision6
Date of issue of marketing authorisation valid throughout the European Union17/03/2011

Contact address:

Eisai Europe Ltd.
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Product information

Product information

18/12/2013  Halaven -EMEA/H/C/002084 -II/0014

Name Language First published Last updated
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014
Halaven : EPAR - Product Information SV = svenska 11/04/2011 07/02/2014

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
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  
Halaven : EPAR - All Authorised presentations SV = svenska 11/04/2011  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Halaven : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 10/05/2012 07/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Halaven : EPAR - Public assessment report SV = svenska 11/04/2011  
CHMP summary of positive opinion for Halaven SV = svenska 21/01/2011  

Authorised

This medicine is approved for use in the European Union

More information on Halaven