Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication

| 27 February 2012 |  By 

The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication.

FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications.

The action followed a public hearing in June 2011 on the subject, as well as lengthy public debate on whether or not Avastin was safe and effective for treating breast cancer. The product's breast cancer indication was ultimately withdrawn on 18 November 2011.

Avastin, manufactured by Roche Holdings AG subsidiary Genentech, was originally granted its indication for breast cancer under an accelerated approval pathway for biological products (the 21 C.F.R §601.4 pathway). As part of a conditional accelerated approval, FDA ordered Genentech to conduct further studies to "verify and describe its clinical benefit." 

Upon submission of those studies, FDA determined that it did not believe that Avastin was beneficial to patients with HER2-negative metastatic breast cancer (MBC), and proposed to withdraw its indication, which it did after the public hearing.

Read more:

FDA - Proposal to Withdraw Approval for the Breast Cancer Indication for Avastin: Decision of the Commissioner

FDA - Final Decision on Withdrawal of Breast Cancer Indication for AVASTIN (Bevacizumab) Following Public Hearing; Availability


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy