What is Abraxane?
Abraxane is a powder that is made up into a suspension for infusion (drip into a vein), containing the active substance paclitaxel.
What is Abraxane used for?
Abraxane is indicated for the treatment of metastatic breast cancer in patients whose initial treatment for metastatic disease is no longer effective and for whom standard therapy containing an "anthracycline" (a type of anticancer medicine) is contraindicated. The term "metastatic" indicates that the tumor 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 administered under the supervision of a qualified oncologist in wards who specialize in the administration of "cytotoxic" (ie cells that can destroy) medicines.
Abraxane is given as monotherapy (alone). The recommended dose is 260 mg per square meter of body surface area (calculated based on the patient's height and weight), to be administered over 30 minutes every three weeks. The dosage can be reduced or treatment stopped in patients who have undesirable effects on the blood or 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 split their internal "skeleton" which allows the cells to divide and multiply. If this skeleton remains intact, the cells cannot divide and therefore die. Abraxane also acts on non-tumor cells (for example, blood and nerve cells), thus causing undesirable effects.
Paclitaxel has been available as an anticancer medicine since 1993. In traditional paclitaxel formulations there are substances that dissolve paclitaxel but which can cause side effects. Abraxane does not contain these substances; in contrast, paclitaxel is bound to a human protein called albumin in tiny particles known as "nanoparticles". In this way it is easier to prepare a suspension of paclitaxel that can be administered by intravenous infusion (into a vein). Nanoparticles can also affect the way the medicine comes
distributed within the body, and therefore on its risks and benefits, compared to traditional medicines containing paclitaxel.
What studies have been carried out on Abraxane?
Abraxane was examined in a main study involving 460 women with metastatic breast cancer, three-quarters of whom had previously received treatment with an anthracycline. About half of the patients who participated in the study had already undergone cancer treatment after the tumor had entered the metastatic phase. Abraxane given as monotherapy was compared with a traditional medicine containing paclitaxel given in combination with other medicines to reduce side effects. The main measure of effectiveness was the number of patients who "responded" to therapy after at least five weeks of treatment. The response to therapy was defined as the disappearance or reduction of at least 30% of the size of the patient's main tumor mass.
What benefit has Abraxane shown during the studies?
Abraxane was more effective than traditional medicines containing paclitaxel. Overall, 31% of women who received Abraxane (72 out of 229) responded to treatment in the main study compared to 16% of women treated with traditional medicines containing paclitaxel (37 out of 225).
Examining only those patients who were treated for the first time for the treatment of metastatic breast cancer, there were no differences between the drugs in terms of efficacy, for example, time to disease progression and survival time. In contrast, in patients who had previously been treated for metastatic breast cancer, these additional assessment parameters showed that Abraxane was more effective than other traditional medicines containing paclitaxel. Therefore, during the evaluation of the medicine the company withdrew the authorization application for the use of Abraxane as a first-line treatment.
What is the risk associated with Abraxane?
The most common side effects reported with Abraxane (seen in more than 1 patient in 10) are: neutropenia (decrease in the number of neutrophils, a type of white blood cell), anemia (decrease in the number of red blood cells), leukopenia (reduction in the number of white blood cells), thrombocytopenia (reduction in blood platelet levels), lymphopenia (reduction in lymphocyte levels, a type of white blood cell count), bone marrow depression (reduced blood cell production), peripheral neuropathy (damage to the nerves of the hands and feet), neuropathy (affecting the nervous system), hypoesthesia (decreased sensitivity), paresthesia (abnormal tingling and prickling sensation), nausea, diarrhea, vomiting, constipation, stomatitis (inflammation of the oral cavity mucosa), alopecia (fall of hair and hair), rash, arthralgia (joint pain), myalgia (muscle pain), loss of appetite, fatigue (tiredness), asthenia (weakness) and pyrexia (fe bbre). 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 during lactation or in patients who have reduced levels of neutrophils in the blood before treatment.
Why has Abraxane been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that Abraxane was more effective than traditional paclitaxel-containing medicines in patients whose first-line treatment was no longer beneficial and who, unlike other paclitaxel-containing medicines, was not necessary concomitant administration of medicines to reduce side effects. The committee determined that the benefits of Abraxane outweigh its risks in the treatment of metastatic breast cancer in patients whose first-line treatment for metastatic disease has not worked and for whom standard anthracycline-containing therapy is not indicated . The Committee therefore recommended the granting of the marketing authorization for Abraxane.
More information on Abraxane:
The European Commission granted a marketing authorization valid throughout the European Union for Abraxane on 11 January 2008 to Abraxis BioScience Limited.
Click here for the full EPAR for Abraxane.
Last update of this summary: 07-2009.
