For doctors

What is it?

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

What is it used for?

Halaven is used on its own to treat locally advanced or metastatic breast cancer which 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 it 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/m 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 it 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 it 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 benefits has it 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?

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 it 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.

Further information

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. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Halaven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2011.

Name

HALAVEN 0.44 mg/ml solution for injection

Composition

One ml contains 0.44 mg of eribulin (as mesylate)
Each 2 ml vial contains 0.88 mg of eribulin (as mesylate)

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Solution for injection.

Clear, colourless aqueous solution.