This information is produced and provided originally by the European Medicines Agency (EMA). We only provide general information and advice from medical professionals should be followed. It is very important to consult more information about the drug, such as side-effects, benefits, indications, approval and so forth. More information concerning the use of this drug is available on the EMA website at www.ema.europa.eu. This information was last updated by EMA in April 2013. It is always important to consult the leaflet information.
Paclitaxel is the active substance in Abraxane® (Abraxis BioScience Limited).
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.
The medicine can only be obtained with a prescription.
What is it?
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 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.
Does it work?
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%. 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.
Is it safe?
The most common side effects with Abraxane® (seen in more than 1 patient in 10) are neutropenia, anemia, leucopenia, thrombocytopenia, lymphopenia, bone marrow suppression, peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia, nausea, diarrhoea, vomiting, constipation, stomatitis, alopecia, rash, joint pain, muscle pain, loss of appetite, tiredness, weakness and 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 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.
This information is based on the Summary for the public of this drug produced by the European Medicines Agency. For more information click here.
To get more professional information about this drug (EMA information) click here.