DOH mulling whether to revoke approval of Avastin for breast cancer

 2011-11-21  It will invite pharmaceutical experts to re-evaluate the benefits and risks of the drug Avastin in treating advanced breast cancer, the Department of Health (DOH) said. According to an official of the Taiwan Food and Drug Administration (TFDA) under the DOH, the bureau has asked the Taiwan branch of Avastin producer Roche AG to submit a report before Nov. 22 on the clinical testing and licensing of Avastin around the world. "Once we receive the report and collect other reference data, we will invite drug experts to evaluate Avastin's benefits and risks before deciding whether to revoke approval of the drug for breast cancer treatment," the official said. The DOH made the announcement a day after the U.S. Food and Drug Administration (USFDA) ruled that Avastin should no longer be used to treat advanced breast cancer. The USFDA said in a statement that Avastin, while hailed for treating colon cancer and certain other malignancies, appeared to be a false hope for breast cancer. "After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," FDA Commissioner Margaret A. Hamburg said in the statement. "Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life." The statement cited Avastin's risks as including severe high blood pressure, bleeding, heart attack or heart failure, and the development of perforations in different parts of the body such as the nose, stomach, and intestines. The drug, however, will remain on the U.S. market to treat certain colon, lung, kidney and brain cancers.