Abraxane

paclitaxel

This document is a summary of the European Public Assessment Report (EPAR) for Abraxane. 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 Abraxane.

What is Abraxane?

Abraxane is a powder that is made up into a suspension for infusion (drip into a vein). It contains the active substance paclitaxel.

What is Abraxane used for?

Abraxane is used to treat metastatic breast cancer in adults whose first treatment has stopped working and for whom standard treatment including an ‘anthracycline’ (a type of anticancer medicine) is 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 Abraxane used?

Abraxane should only be given under the supervision of a specialist cancer doctor in wards that are specialised in giving ‘cytotoxic’ (cell-killing) medicines.

Abraxane is used on its own. The recommended dose is 260 mg per square metre of body surface area (calculated using the patient’s height and weight). It is given over a period of 30 minutes, every three weeks. The dose may be reduced or treatment interrupted in patients who have certain side effects affecting the blood or the nerves.

How does Abraxane work?

The active substance in Abraxane, paclitaxel, belongs to the group of anticancer medicines known as the ‘taxanes’. Paclitaxel blocks the ability of cancer cells to break down their internal ‘skeleton’ that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die. Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.

Paclitaxel has been available as an anticancer medicine since 1993. Conventional types of paclitaxel contain substances that dissolve the paclitaxel, but which can cause hypersensitivity (allergic) reactions. Abraxane does not contain these substances. Instead, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles’. This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein. The nanoparticles may also affect the way the medicine is distributed within the body, and therefore its benefits and risks, in comparison with conventional medicines containing paclitaxel.

How has Abraxane been studied?

Abraxane has been studied in one main study involving 460 women with metastatic breast cancer, around three-quarters of whom had received an anthracycline in the past. Around half of the patients in the study had already received treatments for their cancer after it had become metastatic. Abraxane given on its own was compared with a conventional paclitaxel-containing medicine given together with other medicines to reduce side effects. The main measure of effectiveness was the number of patients who ‘responded’ after at least five weeks of treatment. A response was defined as the patient’s main tumours disappearing or shrinking in size by at least 30%.

What benefit has Abraxane shown during the studies?

Abraxane was more effective than conventional paclitaxel-containing medicines. Overall, in the main study, 31% of the women receiving Abraxane responded to treatment (72 out of 229), compared with 16% of the women receiving conventional paclitaxel-containing medicines (37 out of 225).

When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival. In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before. Therefore, the company withdrew its application for the use of Abraxane as first-line treatment during the assessment of the medicine.

What is the risk associated with Abraxane?

The most common side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), bone marrow suppression (reduced production of blood cells), peripheral neuropathy (nerve damage in the hands and feet), neuropathy (nerve damage), hypoaesthesia (reduced sense of touch), paraesthesia (unusual sensations like pins and needles), nausea (feeling sick), diarrhoea, vomiting, constipation, stomatitis (inflammation of the lining of the mouth), alopecia (hair loss), rash, arthralgia (joint pain), myalgia (muscle pain), loss of appetite, fatigue (tiredness), asthenia (weakness) and pyrexia (fever). For the full list of all side effects reported with Abraxane, see the Package Leaflet.

Abraxane should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients. It must not be used in patients who are breast-feeding or who have low levels of neutrophils in the blood before starting treatment.

Why has Abraxane been approved?

The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, it does not need pre-treatment with other medicines to prevent hypersensitivity reactions. The Committee decided that Abraxane’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Abraxane

The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane on 11 January 2008. The marketing authorisation is valid for five years, after which it can be renewed. The marketing authorisation holder is Celgene Europe Limited.

For more information about treatment with Abraxane, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 12/07/2011 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

29/06/2011  Abraxane -EMEA/H/C/000778 -II/0023

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.

Pharmaco-therapeutic Group

Antineoplastic agents

Therapeutic Indication

Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents