What is Avastin?
Avastin is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance bevacizumab.
What is Avastin used for?
Avastin is used in combination with other anticancer medicines to treat:
- metastatic carcinoma of the colon (large intestine) or rectum, in combination with chemotherapy (drugs to treat tumors) containing a "fluoropyrimidine" (eg fluorouracil-5). The term "metastatic" indicates that the tumor has spread to other parts of the body;
- metastatic breast cancer in combination with paclitaxel or docetaxel;
- advanced, metastatic or relapsed lung cancer, non-small cell, unresectable (ie that cannot be removed by surgery alone) in patients whose cancer cells are not of the "scaly" type, in combination with chemotherapy including a drug a "platinum base"; "advanced" means that the tumor has begun to spread and "in relapse" indicates that there has been a recurrence of the tumor after a previous treatment;
- advanced or metastatic renal cell carcinoma in combination with interferon alfa2a.
The medicine can only be obtained with a prescription .
How is Avastin used?
Avastin should be administered under the supervision of a doctor experienced in the use of anticancer medicines.
The first Avastin infusion should last 90 minutes, but subsequent infusions can be given in a shorter period of time if the first was well tolerated. The dose is between 5 and 15 mg per kilogram of body weight every two or three weeks, depending on the type of cancer to be treated. It is recommended to continue treatment until the disease gets worse. The doctor may decide to stop or stop treatment if the patient develops certain side effects. For more detailed information, see the Summary of Product Characteristics (also included in the EPAR).
How does Avastin work?
Bevacizumab, the active ingredient in Avastin, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure
(the antigen) present on certain cells of the body or in the blood. Bevacizumab was made to attach itself to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and contributes to the development of blood vessels. Once Avastin binds to VEGF, it prevents it from working. The tumor cells therefore are no longer able to produce new blood vessels and die due to lack of oxygen and nutrition, with a consequent slowing of tumor growth.
How has Avastin been studied?
With regard to colon and rectal carcinoma, the effects of adding Avastin to combinations of anticancer drugs containing a fluoropyrimidine have been observed in three main studies. The first two studies included patients in whom the disease had developed metastases and who received treatment for the first time ("first line" treatment): the first study (923 patients) compared chemotherapy with and without the addition of Avastin. The second study (1 401 patients) compared the addition of Avastin with that of a placebo (a dummy treatment). The third study included 829 patients who had not responded to previous treatment, including a fluoropyrimidine and irinotecan (another anticancer medicine).
For breast cancer, Avastin has been studied in two main studies. The first study compared the effectiveness of adding Avastin to paclitaxel with that of paclitaxel alone on 722 patients. The second observed the effectiveness of the addition of Avastin or a placebo to docetaxel on 736 patients.
With regard to lung cancer, Avastin was examined in 878 patients. The efficacy of the combination of Avastin and platinum-based chemotherapy with that of chemotherapy alone was compared during the study.
Regarding renal carcinoma, Avastin has been studied in 649 patients with advanced or metastatic cancer. The study compared Avastin with placebo, both given in combination with interferon alfa2a.
In all the studies, the main measure of effectiveness was both the overall survival time and the survival time without disease progression (how long the patients lived without their disease getting worse).
What benefit has Avastin shown during the studies?
The addition of Avastin to therapy for the treatment of colon or rectum cancer has prolonged the survival time and the progression-free survival period, when added to fluoropyrimidine-containing chemotherapy. In the first study of previously untreated patients, the average survival time was 20.3 months for treated patients adding Avastin and 15.6 months for those receiving chemotherapy alone. In the second study, the progression-free survival period was 9.4 months in patients who received Avastin and 8.0 months in those who received placebo. In previously treated patients, the overall survival time was 13.0 months with the addition of Avastin and 10.8 months with chemotherapy alone.
In breast cancer, the addition of Avastin also increased progression-free survival times. When added to paclixatel, the average progression-free survival time was 11.4 months, compared to 5.8 months for patients who received paclitaxel alone. When Avastin was added to docetaxel this time was 10.1 months compared to 8.2 months with the addition of placebo.
In lung cancer, the average survival time was 12.3 months in patients who took Avastin with paclitaxel and carboplatin and 10.3 months for patients who took only paclitaxel and carboplatin.
In renal cancer, the average progression-free survival time was 10.2 months in patients who received Avastin and 5.4 months in those who received placebo.
What is the risk associated with Avastin?
The most common side effects seen in patients taking Avastin with or without chemotherapy (seen in more than 1 patient in 10) are: febrile neutropenia (low white blood cell count), leukopenia (low white blood cell count), thrombocytopenia ( reduction in blood platelet levels), neutropenia (decrease in the number of neutrophils, a type of white blood cell, present in the blood), peripheral sensory neuropathy (affecting the nervous system at the level of
hands and feet), hypertension (increased blood pressure), diarrhea, nausea, vomiting, asthenia (weakness), fatigue, dysgeusia (altered taste sensitivity), headache, eye disorders, increased tearing, dyspnea (difficulty breathing) ), epistaxis (loss of blood from the nose), rhinitis (stuffy nose), constipation, stomatitis (inflammation of the mucous membrane of the oral cavity), rectal haemorrhage (bleeding from the rectum), exfoliative dermatitis (desquamation), dry skin, discoloration of the skin, arthralgia (joint pain), proteinuria (protein in the urine), pyrexia (fever) and mucosal pain and inflammation (inflammation of the body's wet surfaces). The most serious side effects are gastrointestinal perforation, fistulas (ducts of pathological origin between organs), hemorrhage and arterial thromboembolism (occlusion of an artery due to blood clots). For the full list of all side effects reported with Avastin, see the Package Leaflet.
Avastin should not be used in people who may be hypersensitive (allergic) to bevacizumab or any of the other ingredients, to products made from Chinese hamster ovary cells or other recombinant antibodies. It must not be given to pregnant women.
Why has Avastin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in combination with other anticancer drugs, the benefits of Avastin outweigh its risks for the treatment of patients with metastatic cancer of the colon or rectum, and for the treatment of first line of patients with metastatic breast cancer, metastatic advanced non-resectable non-small cell lung cancer or relapse with predominantly non-squamous cell histology and advanced and / or metastatic renal cell carcinoma. The Committee recommended that Avastin be given marketing authorization.
More information on Avastin
On 12 January 2005, the European Commission granted Avastin a marketing authorization valid throughout the European Union to Roche Registration Limited.
The full EPAR for Avastin can be found here.
Last update of this summary: 07-2009.
