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 cancer medicine that contains the active substance eribulin. It is available as a solution for injection.

What is Halaven used for?

Halaven is used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer. Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, 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 (into a vein) 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 per /m2 of body surface area given into a vein over two to five minutes on days 1 and 8 of each cycle. Doctors should consider giving patients an antiemetic (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?

Halaven was studied in two main studies involving a total of 1,864 patients. In the first 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 cancer medicine chosen by their doctor. The main measure of effectiveness was overall survival (how long the patients lived).

A second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane. The study compared Halaven with capecitabine (another cancer medicine). The main measures of effectiveness were overall survival and progression-free survival (how long the patients lived without their disease getting worse).

What benefit has Halaven shown during the studies?

In the first study, 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.

In the second study, there was no significant difference in the average progression-free survival with Halaven (4.1 months) compared with capecitabine (4.2 months) or in the average overall survival with Halaven (15.9 months) compared with capecitabine (14.5 months).

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, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss. For the full list of all side effects reported with Halaven, see the package leaflet.

Halaven should not be used in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

Why has Halaven been approved?

The CHMP noted that, when Halaven was used as a third-line therapy (after at least two previous treatments with cancer medicines for advanced/metastatic disease), it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines. When Halaven was used as a second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile.

The CHMP decided that Halaven’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that Halaven 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 Halaven, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Halaven

The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.

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 01/08/2014
Halaven : EPAR - Summary for the public ES = español 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public CS = čeština 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public DA = dansk 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public DE = Deutsch 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public ET = eesti keel 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public EL = elliniká 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public EN = English 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public FR = français 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public IT = italiano 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public LV = latviešu valoda 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public LT = lietuvių kalba 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public HU = magyar 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public MT = Malti 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public NL = Nederlands 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public PL = polski 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public PT = português 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public RO = română 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public SK = slovenčina 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public SL = slovenščina 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public FI = suomi 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public SV = svenska 11/04/2011 01/08/2014
Halaven : EPAR - Summary for the public HR = Hrvatski 11/04/2011 01/08/2014

This EPAR was last updated on 01/08/2014 .

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.

Revision7
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

27/06/2014  Halaven -EMEA/H/C/002084 -II/0011

Name Language First published Last updated
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014
Halaven : EPAR - Product Information HR = Hrvatski 11/04/2011 01/08/2014

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 HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  
Halaven : EPAR - All Authorised presentations HR = Hrvatski 11/04/2011  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union

More information on Halaven