Avastin® (bevacizumab) - FDA Proposes Removal of Breast Cancer Indication
November 21, 2011
FDA recently announced that bevacizumab (Avastin) is no longer approved for use in metastatic breast cancer. In December 2010, FDA recommend that Genentech remove the breast cancer indication from the project label. Data from the clinical studies completed after the approval of bevacizumab do not show bevacizumab to be effective or safe in the treatment of breast cancer. Bevacizumab may still be marketed for its remaining approved indications, including advanced colon, lung, kidney, and brain cancers.
Bevacizumab was approved in 2008 for treatment of metastatic breast cancer through an accelerated approval program, based on 1 study suggesting improved progression free survival. Genentech submitted 2 additional studies required by FDA to supplement data from the accelerated approval. FDA reviewed these 2 studies and 2 other studies to assess the safety and efficacy of bevacizumab in breast cancer. The data did not show a benefit in progression free survival or overall survival. There was also an increase in serious adverse events seen in the two trials submitted by Genentech. Serious adverse events reported include perforations in multiple sites of the body (nose, stomach, and intestines), massive bleeding, severely high blood pressure, heart failure, heart attack, kidney dysfunction, and blood clots in arteries and veins. FDA determined that the risks associated with bevacizumab treatment in breast cancer outweighed any potential benefits. FDA’s decision to remove the breast cancer indication will not affect other labeled indications for bevacizumab.
After the initial recommendation, FDA allowed Genentech the opportunity to comment on to the proposed withdrawal. Genentech requested an official hearing on the proposal, with the final decision to be made by Commissioner Hamburg. The hearing was held in late June 2011, with the FDA's Oncologic Drugs Advisory Committee voting unanimously in favor of withdrawing approval of bevacizumab for breast cancer. The public docket remained open until August 4, 2011 and the Commissioner's final decision announced November 18, 2011.
Oncologists currently treating patients with bevacizumab should use their clinical judgement to assess the appropriateness of continuing bevacizumab or changing therapies. Patients who are being treated with bevacizumab should discuss their treatment options with their oncologist.
Additional information is available at the following links:
- FDA Newsroom statement
- FDA Press Releases: November 2011
- FDA Press Releases: December 2010
- Questions and Answers: November 2011
- Questions and Answers: December 2010
- FDA Hearing
- MedWatch Alert, December 2010
- Avastin Decision Memo, December 2010
November 21, 2011; December 20, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.