Association of AVASTIN^® (bevacizumab) with tracheo-esophageal fistula

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This is duplicated text of a letter from Hoffman-La Roche Ltd.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on AVASTIN^® (bevacizumab)

June 2007

Subject: Association of AVASTIN^® (bevacizumab) with tracheo-esophageal fistulas

Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning AVASTIN (bevacizumab).

AVASTIN is used in combination with a specific type of chemotherapy for the treatment of cancer of the bowel and rectum which has spread to other sites. Please note the following new safety information for the use of AVASTIN:

Tracheo-esophageal Fistulas

Tracheo-esophageal fistula is an abnormal connection in one or more places between the esophagus (the tube that leads from the throat to the stomach) and the trachea (the tube that leads from the throat to the lungs, also known as the windpipe). Normally, the esophagus and the trachea are two separate tubes that are not connected. Tracheo-esophageal fistula is also known as TE fistula.

In a clinical trial conducted by a physician in the U.S. using AVASTIN in combination with chemotherapy and radiation in patients with small cell lung cancer, a total of two (2) confirmed cases of TE fistulas have been reported. One (1) of these cases resulted in death. A third case that resulted in death was also reported, in which TE fistula was suspected but not confirmed. TE fistulas have also been reported in patients using AVASTIN to treat other types of lung cancer and cancer of the esophagus. A direct cause and effect between AVASTIN and these events has not been established, but cannot be ruled out. AVASTIN should no longer be given to patients who develop a TE fistula.

In Canada, AVASTIN is not authorized for use in lung cancer or in combination with radiation for any other cancer.

Hoffmann-La Roche Limited has sent a letter to healthcare professionals informing them of this new safety information. A copy of the healthcare professional letter and this communication are available on the Health Canada website.

The prescribing information for AVASTIN will be revised to include more information on the association of AVASTIN with fistulas.

Some examples of signs and symptoms of TE fistula are:

• Chest pain, shortness of breath, wheezing or labored breathing.
• Coughing or choking when eating or drinking.
• Coughing up food or liquids.
• Wheezing sounds following every breath.

If you develop any of the above or any other unusual signs or symptoms, please contact your doctor or healthcare professional immediately.

Managing marketed health product-related adverse reactions depends on health-care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving AVASTIN should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:

Sincerely,

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited