What is Abraxane?
Abraxane is a powder that is made up into a suspension for infusion (drip into a vein), which contains 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" 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 administered under the supervision of a qualified oncologist in wards specializing in the administration of 'cytotoxic' (ie cell-destroying) 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), given over 30 minutes every three weeks. The dosage may be reduced or the treatment stopped in patients who have side effects affecting the blood or nerves.
How does Abraxane work?
The active substance in Abraxane, paclitaxel, belongs to the group of anticancer medicines known as 'taxanes'. Paclitaxel blocks the ability of cancer cells to break down 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-cancer cells (for example, blood and nerve cells), thus causing side effects.
Paclitaxel has been available as an anticancer medicine since 1993. In traditional formulations of paclitaxel there are substances that dissolve paclitaxel but 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". This makes it easier to prepare a paclitaxel suspension that can be given by infusion into a vein (into a vein). The nanoparticles can also affect how the medicine comes
distributed within the body, and therefore on its risks and benefits, compared to traditional medicines containing paclitaxel.
How has Abraxane been studied?
Abraxane was studied in one 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 treatment. cancer after the cancer had entered the metastatic phase. Abraxane given alone was compared with a traditional medicine containing paclitaxel given in combination with other medicines to reduce their side effects. The main measure of effectiveness was the number of patients who they "responded" to therapy after at least five weeks of treatment. Response to therapy was defined as the disappearance or reduction of at least 30% in the size of the patient's main tumor mass.
What benefit has Abraxane shown during the studies?
Abraxane was more effective than traditional paclitaxel-containing medicines. Overall, 31% of women given Abraxane (72 out of 229) responded to treatment in the main study compared with 16% of women treated with traditional paclitaxel-containing medicines (37 out of 225).
Examining only patients undergoing treatment for metastatic breast cancer for the first time, there was no difference between the drugs in terms of efficacy, for example, in time to disease progression and survival time. In contrast, in patients who had previously been treated for metastatic breast cancer, these additional scores showed that Abraxane was more effective than other traditional paclitaxel-containing medicines. Therefore, during the evaluation of the medicine, the company withdrew its application for authorization for the use of Abraxane as a first-line treatment.
What is the risk associated with Abraxane?
The most common side effects seen with Abraxane (seen in more than 1 in 10 patients) are: neutropenia (decrease in the number of neutrophils, a type of white blood cell), anemia (decrease in the number of red blood cells), leukopenia (decrease in the number of blood cells), thrombocytopenia (decreased levels of blood platelets), lymphopenia (decreased levels of lymphocytes, a type of white blood cells), bone marrow depression (decreased production of blood cells), peripheral neuropathy (damage to the nerves of the hands and feet), neuropathy (affection of the nervous system), hypoesthesia (decreased sensitivity), paraesthesia (abnormal tingling and pricking sensation), nausea, diarrhea, vomiting, constipation, stomatitis (inflammation of the mucous membrane of the oral cavity), alopecia (fall of hair and dander), rash, arthralgia (joint pain), myalgia (muscle pain), loss of appetite, exhaustion (tiredness), asthenia (weakness) and pyrexia (fever ). For the full list of side effects reported with Abraxane, see the Package Leaflet.
Abraxane must not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients. It should not be used during breastfeeding or by patients who have low levels of neutrophils in their blood before starting 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 no longer showed benefit and that, unlike other paclitaxel-containing medicines, it is not concomitant administration of medicinal products is required to reduce undesirable effects. The Committee concluded that Abraxane's benefits outweigh its risks in the treatment of metastatic breast cancer in patients in whom first-line treatment for metastatic disease has failed and for whom standard anthracycline-containing therapy is not indicated. . The Committee therefore recommended the granting of a marketing authorization for Abraxane.
Other information about Abraxane:
On 11 January 2008, the European Commission granted Abraxis BioScience Limited a marketing authorization valid throughout the European Union for Abraxane.
For the full version of Abraxane's EPAR click here.
Last update of this summary: 07-2009.
The information on Abraxane - paclitaxel published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
