The public hearing on the Center for Drug Evaluation and Research’s December 2010 proposal to withdraw approval of the metastatic breast cancer indication for Avastin is now complete. The Center and Genentech are scheduled to provide additional written submissions by July 28, 2011, and the docket will remain open for public comment until that date.
Following the closing of the docket, the Center for Drug Evaluation and Research will await Commissioner Hamburg’s final decision on Avastin’s use for metastatic breast cancer. The Commissioner’s decision related to breast cancer will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers. That is, regardless of the final decision on metastatic breast cancer approval, Avastin will remain on the market.
The Center for Drug Evaluation and Research would like to thank the patients, their families, and other stakeholders who participated in the hearing and have shared their perspectives with us over the past several months.
We want to reassure patients with serious and potentially life-threatening diseases and their families that the Center for Drug Evaluation and Research remains committed to approving safe and effective new cancer options for patients.
We encourage companies to continue doing innovative research that will identify new therapies to treat these diseases.
FDA has received a submission from Genentech supporting its request for a Notice of Opportunity for a Hearing. The information has been submitted to the docket (FDA-2010-N-0621) and was due to the agency by close of business today. We are at the beginning stages of this process and the agency will review the materials in order to make a determination on whether a public hearing for Avastin in metastatic breast cancer is warranted.
Avastin's indications for colon, lung, kidney and brain cancers will not be affected by this process or today's submission.
The agency will work diligently to determine the next steps for this proceeding. Avastin for use in women with metastatic breast cancer is still an FDA-approved indication.
Avastin is an injectable cancer medication that works by blocking a protein that is important for the formation of blood vessels. Since tumors rely on blood vessels to get the nutrients they need to survive, the drug is thought to work by preventing the formation of new blood vessels that feed the tumor. Avastin was first approved in 2004 for treatment of advanced colon cancer and has been approved since for advanced lung (2006), kidney and brain (glioblastoma) cancers (2009). Avastin was approved for metastatic breast cancer in 2008 under the accelerated approval program. Under the accelerated approval program, a drug may be approved based on results of clinical data that suggest the drug has an important clinical benefit. However, additional information is needed to confirm the data.
The FDA has proposed withdrawing Avastin's indication to treat women with metastatic breast cancer. The agency is making this announcement after deciding there is not enough evidence that the drug is safe and effective for this one indication. The announcement will not have any immediate effect on the approval of Avastin to treat metastatic breast cancer and there will be no change to product labeling. Since the marketing approval remains in effect, patients with breast cancer will still have access to the drug until a final decision has been made.
If you would like to make a statement regarding this topic or provide other comments in a paper or electronic submission, please see these instructions for submissions.
FDA begins process to remove breast cancer indication from Avastin label[ARCHIVED]
FDA new release (12/16/2010)
Questions and Answers about Avastin
Avastin Decision Memo(PDF - 125KB) Letter to the Breast Cancer Community(PDF - 53KB) Podcast by Dr. Janet Woodcock(MP3 - 7.8MB) [ARCHIVED] Transcript: Avastin Podcast by Dr. Janet Woodcock[ARCHIVED]
- Slide Presentations, July 20, 2010, Oncologic Drugs Advisory Committee Meeting [ARCHIVED]
- Slide Presentations, December 5, 2007, Oncologic Drugs Advisory Committee Meeting
Labeling and Regulatory History from Drugs@FDA
Additional Safety Information
MedWatch Safety Alert (7/14/2008)