FDA Commissioner Announces Final Decision on Avastin for Metastatic Breast Cancer

FDA Commissioner Announces Final Decision on Avastin for Metastatic Breast Cancer. U.S. Food and Drug Administration (FDA) Commissioner revokes approval of Avastin for treatment of metastatic breast cancer (mBC) in the United States This action concludes the FDA's review of Avastin's use for mBC This decision does not impact Avastin's approved uses for other cancer types in the United States or other countries This decision also does not impact the approval of Avastin for mBC in more than 80 other countries Roche will start a new trial of Avastin plus paclitaxel in mBC Roche announced today that the FDA Commissioner is revoking the approval of Avastin (bevacizumab) for the treatment of mBC in the United States.   "We are disappointed with the outcome.  We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said Hal Barron, M.D., chief medical officer and head, Global Product Development.  "Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."   - About Avastin: Over 5 Years of Transforming Cancer Care. With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.