June 29, 2011 -- An FDA panel has recommended that the drug Avastin no longer be sold as a treatment for breast cancer.
The unanimous recommendation came after experts concluded that Avastin offers breast cancer patients no substantial benefits but at the same time carries substantial risks.
The panel's decision does not affect other uses for which Avastin is approved, including advanced non-small-cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, and glioblastoma brain tumors.
But if the FDA follows the panel's recommendation, it would be a setback for the treatment of advanced metastatic breast cancer.
The panel's decision was a blow to California-based Genentech, which manufacturers Avastin, known generically as bevacizumab. The company secured fast-track approval for the drug in 2008 after early studies showed it slowed progression of a severe form of breast cancer by an average of 5.5 months.
But later studies failed to back up those earlier findings. The FDA panel concluded that overall, Avastin does not help breast cancer patients live substantially longer or enjoy better quality of life with the disease. The drug carries significant, sometimes fatal, cardiovascular and other side effects.
The recommendation could lead FDA Commissioner Margaret Hamburg, MD, to suspend marketing of Avastin for the treatment of breast cancer.
"She will make a decision based on all this information," said Karen Midthun, MD, who directs FDA's Center for Biologics Evaluation and Research. "I cannot tell you at this point when the decision will be finalized and issued," Midthun said, as she ended a two-day meeting on Avastin.