Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin)

Hearing Information

On June 28 and 29, 2011, the Food and Drug Administration (FDA) conducted a hearing on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw accelerated approval of the breast cancer indication for bevacizumab (Avastin). Genentech, Inc., and CDER were the parties to the hearing.

• Docket FDA-2010-N-0621 is available on Regulations.gov. All documents filed or posted in this matter are available for public review under Docket No. FDA-2010-N-0621 in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
• You may submit electronic or written comments to Regulations.gov. Comments must be submitted by July 28, 2011. You may also submit written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
• Federal Register Notice

Video Recordings

You may access video recordings of the hearing at the following links:

• Avastin Hearing, June 28: Video Recording
• Avastin Hearing, June 29: Video Recording

Transcripts

You may access transcripts of the hearing at the following links:

• Avastin Hearing, June 28: Full Transcript (PDF - 3826KB)
• Avastin Hearing, June 28: Condensed Transcript (PDF - 7369KB)
• Avastin Hearing, June 29: Full Transcript (PDF - 3315KB)
• Avastin Hearing, June 29: Condensed Transcript (PDF - 6096KB)
• Presiding Officer's Closing Statement

Media

Media with questions about the hearing should contact the FDA's Office of Public Affairs. For questions involving the Office of the Commissioner, contact Karen Riley at (301) 796-4674, or karen.riley@fda.hhs.gov. For questions involving the views of the Center for Drug Evaluation and Research, contact Erica Jefferson at (301) 796-4988, or erica.jefferson@fda.hhs.gov.

Oncologic Drugs Advisory Committee Members

Frank Balis, M.D. (Voting Member)
The Louis and Amelia Canuso Family Endowed Chair for Clinical Research in Oncology
The Children’s Hospital of Philadelphia
University of Pennsylvania School of Medicine
Philadelphia, PA 19104

Ralph Freedman, M.D., Ph.D. (Voting Member)
Clinical Professor
Department of Gynecologic Oncology
The University of Texas
M.D. Anderson Cancer Center
Houston, TX  77230

Brent Logan, Ph.D. (Voting Member)
Associate Professor of Biostatistics
Division of Biostatistics
Medical College of Wisconsin
Milwaukee, WI 53226

Mikkael Sekeres, M.D., M.S. (Voting Member)
Associate Professor of Medicine Staff
Cleveland Clinic Taussig Cancer Institute
Department of Hematologic Oncology and Blood Disorders
Cleveland, OH 44195

Wyndham Wilson, M.D., Ph.D. (Voting Member)
Chief, Lymphoma Therapeutics Section
Metabolism Branch
Center for Cancer Research
National Cancer Institute
Rockville, MD 20892

Gregory Curt, M.D. (Industry Representative, Non-Voting Member)
U.S. Medical Science Lead, Emerging Products
AstraZeneca Oncology
Garrett Park, MD 20896

Natalie Compagni-Portis, Psy.D. (Patient Representative, Temporary Voting Member )
Oakland, CA 94611