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 attached to a human protein called albumin.
What is Abraxane used for?
Abraxane is used to treat the following cancers in adults:
•metastatic breast cancer, when the first treatment has stopped working and standard treatment including an ‘anthracycline’ (another type of cancer medicine) is not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body.
•metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine.
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 units that are specialised in giving ‘cytotoxic’
Abraxane is given into a vein over a period of 30 minutes.
In metastatic breast cancer Abraxane is given on its own every three weeks. The recommended dose is 260 mg per square metre of body surface area (calculated using the patient’s height and weight).
In metastatic adenocarcinoma of the pancreas Abraxane is given in
For additional information, see the summary of product characteristics (also part of the EPAR).
How does Abraxane work?
The active substance in Abraxane, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes’. Paclitaxel blocks a stage of cell division in which the cell’s internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping this structure intact the cells cannot divide and they eventually die. Abraxane also affects
Paclitaxel has been available as a cancer medicine since 1993. In Abraxane, unlike conventional
How has Abraxane been studied?
For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around
For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone. The main measure of effectiveness was how long patients lived.
What benefit has Abraxane shown during the studies?
In metastatic breast cancer, Abraxane was more effective than conventional
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
In metastatic adenocarcinoma of the pancreas, Abraxane was shown to improve overall survival. Patients survived for around 8.5 months on treatment with the combination of Abraxane and gemcitabine, compared with 6.7 months on gemcitabine alone.
What is the risk associated with Abraxane?
The most common important side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cells), gastrointestinal disorders (disorders of the digestive system), peripheral neuropathy (nerve damage including damage to the nerves in the hand and feet), arthralgia (joint pain) and myalgia (muscle pain). For the full list of all side effects reported with Abraxane, see the package leaflet.
Abraxane must not be used in patients who are
Why has Abraxane been approved?
The CHMP noted that Abraxane was more effective than conventional
What measures are being taken to ensure the safe and effective use of Abraxane?
A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abraxane, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Abraxane
The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane on 11 January 2008.
The full EPAR for Abraxane can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Abraxane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in