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FDA Invites Comments on Avastin

Women with breast cancer, providers, advocates invited to testify on fate of bevacizumab

May 11, 2011

Written By Janine E. Guglielmino, MA, Director, Programs and Strategic Initiatives

Reversing course, FDA officials have invited the public to testify at a hearing that will argue the merits of bevacizumab (Avastin) as an approved treatment for HER2 negative metastatic breast cancer.

The hearing, to be held June 28-29, in Silver Spring, Md., is a legal case between Genentech, the manufacturer of bevacizumab, and the Center for Drug Evaluation and Research, the branch of FDA responsible for the safety of medicines. Any ruling from this hearing is final, although Genentech may pursue its case via the U.S. court system.

Witnesses at the hearing will debate the science behind the clinical research that led to FDA’s initial accelerated approval of bevacizumab, as well as the relevance and scientific merit of follow-up trials.

Members of the public may testify during the first two hours of the hearing on Tuesday, June 28. Anyone affected by the ruling may speak, including women with metastatic breast cancer, healthcare providers, caregivers and advocacy groups. No special expertise is necessary, and all viewpoints are welcomed.

How to Participate

FDA offers four ways to take part in the hearing process:

Give oral testimony. To speak at the hearing, you must register with Talisha.Williams@fda.hhs.gov at the Office of the Ombudsman, Office of the Commissioner of FDA, by Friday, May 27. You may call (301) 796-8530 or write your request to Ms. Williams at 10903 New Hampshire Avenue., Silver Spring, MD 20993. Provide your name, job title, professional affiliation, address, telephone and fax, email address and the name of any organizations you represent. Summarize what you want to say and how long you need to say it; FDA will allot time based on the number of requests to speak. The agency will accommodate as many speakers as possible within the two-hour window.

Submit written comments. Contribute to the public record for the proceedings. Write a letter and upload it before Tuesday, June 14, to regulations.gov under docket number FDA-2010-N-0621. To mail your comments, make four copies and send them to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Attend the hearing. Up to 300 people may go to the hearing, but you must pre-register. Sign up starting Friday, May 27, at the FDA's website. The hearing will take place at FDA's White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Watch the hearing. An unspecified number of people can watch the hearing online as a webcast. By Friday, May 20, FDA will post registration information on its website.

Background of Bevacizumab Hearing

In 2008, FDA granted accelerated approval to bevacizumab as initial treatment for HER2 negative metastatic breast cancer. The approval was based on preliminary findings from the E-2100 clinical trial that showed increased progression-free survival among women who added bevacizumab to paclitaxel chemotherapy.

The subsequent studies AVADO and RIBBON-1 failed to confirm an overall survival benefit, and participants did not live as long without progression of disease as they had in E-2100. In addition, some women had severe side effects that contributed to FDA's overall appraisal that the benefits of bevacizumab do not outweigh its risks. In December 2010, the agency moved to revoke the accelerated approval.

Read Living Beyond Breast Cancer’s statement on bevacizumab.

Read what LBBC's medical advisors are saying about bevacizumab. We invite providers to submit comments to lbbc.org.

Read what women are saying about bevacizumab and submit your own comments to lbbc.org.

Learn more about the FDA's medicine approval process and bevacizumab.

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