The FDA’s Oncologic Drug Advisory Committee (ODAC) recommended on June 29, 2011, that the agency withdraw its approval of bevacizumab (Avastin) in combination with paclitaxel chemotherapy for first-line HER2-negative metastatic breast cancer. However, the docket remained open for public comment until July 28, 2011—the due date for additional written submissions from bevacizumab manufacturer Genentech as well as the Center for Drug Evaluation and Research, the FDA office that proposed in December 2010 to withdraw approval of the breast cancer indication.
The bevacizumab/paclitaxel regimen was approved in February 2008 under the FDA’s accelerated approval program based on the results of a clinical trial known as “E2100.” In July 2010, an independent advisory committee composed primarily of oncologists voted 12-1 to remove the breast cancer indication from the bevacizumab label. According to the FDA, studies failed to confirm the survival benefit observed in the original trial, but demonstrated serious side effects.
ODAC’s recommendation is not the final decision of the FDA. Agency commissioner Joan Hamburg is expected to make her final decision sometime after the docket closes. Any decision will affect the use of bevacizumab only in relation to breast cancer; the drug is also indicated for use in the treatment of colon, lung, kidney, and brain cancers (www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformation forPatientsandProviders/ucm 193900.htm).
“We are very disappointed by the committee’s recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” commented Hal Barron, MD, the chief medical officer of Genentech and head of global product development for the company, in a statement issued by Genentech (www.gene.com/gene/news/press-releases/display.do?method=detail&id=13528). “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.” ONA