Author: Roche Registration Ltd.


Long information

What is it?

Avastin is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance bevacizumab.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Avastin is used with other anticancer medicines to treat the following types of cancer:

metastatic cancer of the colon or rectum large intestine, in combination with chemotherapy medicines to treat cancer that includes a fluoropyrimidine such as 5-fluorouracil. Metastatic means that the cancer has spread to other parts of the body

metastatic breast cancer, in combination with paclitaxel

advanced, metastatic or recurrent non-small cell lung cancer that is unresectable cannot be removed by surgery alone in patients whose cancer cells are not of the squamous type, in combination with chemotherapy that includes a platinum-based medicine. Advanced means that the cancer has started to spread, and recurrent means that the cancer has come back after previous treatment

advanced or metastatic kidney cancer, in combination with interferon alfa-2a.

The medicine can only be obtained with a prescription.

How is it used?

Avastin treatment should be supervised by a doctor who has experience in the use of cancer treatments.

The first infusion of Avastin should last 90 minutes, but subsequent infusions may be given over a shorter period if the first infusion is tolerated well. The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated. The treatment is continued until the disease gets worse. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects. See the summary of product characteristics (also part of the EPAR) for more information.

How does it work?

The active substance in Avastin, bevacizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Bevacizumab has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow. By attaching to VEGF, Avastin stops it having an effect. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.

How has it been studied?

In cancer of the colon or rectum, the effects of adding Avastin to chemotherapy including a fluoropyrimidine have been studied in three main studies. The first two studies involved patients whose metastatic disease was being treated for the first time (?first-line? treatment): the first study (in 923 patients) and the second study (in 1,401 patients) compared Avastin with placebo (a dummy treatment) when given in combination with chemotherapy. The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan (another anticancer medicine).

In breast cancer, Avastin has been studied in one main study which compared the effects of Avastin with paclitaxel to paclitaxel alone in 722 patients.

In lung cancer, Avastin has been studied in 878 patients. The study compared the effects of Avastin with platinum-based chemotherapy to chemotherapy alone.

In kidney cancer, Avastin has been studied in 649 patients with advanced or metastatic disease. The study compared Avastin with placebo when given in combination with interferon alfa-2a.

In all of the studies, the main measure of effectiveness was either overall survival or progression-free survival (how long the patients lived without their disease getting worse).

What benefits has it shown during the studies?

In cancer of the colon or rectum, Avastin increased both overall and progression-free survival when it was added to fluoropyrimidine-containing chemotherapy. In the first study of previously untreated patients, the average overall survival was 20.3 months in the patients adding Avastin and 15.6 months in those receiving chemotherapy alone. In the second study, progression-free survival was 9.4 months in the patients receiving Avastin and 8.0 months in those receiving placebo. In previously treated patients, overall survival was 13.0 months in the patients adding Avastin and 10.8 months in those receiving chemotherapy alone.

In breast cancer, adding Avastin also increased progression-free survival. When it was added to paclitaxel, the average progression-free survival was 11.4 months, compared with 5.8 months in those receiving paclitaxel alone.

In lung cancer, the average overall survival was 12.3 months in the patients taking Avastin with paclitaxel and carboplatin, and 10.3 months for those taking paclitaxel and carboplatin alone.

In kidney cancer, the average progression-free survival was 10.2 months in the patients receiving Avastin and 5.4 months in those receiving placebo.

What is the risk associated?

The most common side effects with Avastin (seen in more than 1 patient in 10) are neutropenia and febrile neutropenia (low white blood cell counts with or without fever), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), peripheral sensory neuropathy (nerve damage in the hands and feet), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, asthenia (weakness), fatigue (tiredness), loss of appetite, dysgeusia (taste disturbances), headache, eye disorders, increased lacrimation (tear production), dyspnoea (difficulty breathing), epistaxis (nosebleeds), rhinitis (blocked nose), constipation, stomatitis (inflammation of the lining of the mouth), rectal haemorrhage (bleeding from the rectum), exfoliative dermatitis (flaky skin), dry skin, skin discoloration, arthralgia (joint pain), proteinuria (protein in the urine), pyrexia (fever), pain and mucosal inflammation (inflammation of the moist body surfaces). 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 Chinese hamster ovary cell products or other recombinant antibodies. It must not be given to pregnant women.

Why has it been approved?

The CHMP decided that Avastin?s benefits are greater than its risks and recommended that it be given marketing authorisation.

In metastatic breast cancer, Avastin is approved for use in combination with paclitaxel. Formerly Avastin was also approved for use in combination with docetaxel (another anticancer medicine), but in December 2010 this indication was removed following a review of the relevant data.1

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