Postmarket Drug Safety Information for Patients and Providers > Avastin (bevacizumab) Information

Avastin (bevacizumab) Information
Update, 6/29/2011The 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.
Postmarket Drug Safety Information for Patients and Providers > Avastin (bevacizumab) Information