FDA Moves to Pull Avastin Breast Cancer Approval
Roche/Genentech Will Fight Avastin/Breast Cancer Decision at FDA Hearing
Avastin Breast-Cancer Approval: FDA, European Medicines Agency Differ continued...
The three new trials used different chemotherapies than the first trial. Because of this, the European drug agency yesterday reaffirmed its approval of Avastin plus paclitaxel, but not for other chemotherapy combinations. The FDA feels differently, said Janet Woodcock, MD, director of the FDA's center for drug evaluation and research.
"The EMA accepts the magnitude of [delayed tumor progression seen in the first study] as a clinical benefit," Woodcock said at the news conference. "Now we have other trials with a much smaller increase in [delayed tumor progression], no additional benefit, increased side effects, and no increase in survival. So these subsequent trials did not show a clinical benefit."
The studies did show that Avastin carries a number of risks. In addition to the common side effects of nosebleed and high blood pressure, serious side effects include massive bleeding; perforation of the nose, stomach, and intestines; severe high blood pressure; blood clots, heart attack; kidney damage, wounds that do not heal; and a condition called RPLS characterized by headache, confusion, seizures, and vision loss.
Despite these risks, many women facing metastatic breast cancer have petitioned the FDA to retain their access to Avastin. Without FDA approval, Avastin might not be reimbursed by insurance companies -- or by Medicare/Medicaid, which had postponed its decision on whether to cover this use of the drug pending the FDA action. The wholesale price of Avastin is $7,500 a month, which does not include infusion costs.
The FDA is not allowed to consider cost in its approval decisions.
The FDA says it will work with Genentech to design clinical trials to explore whether there is a subset of women with metastatic breast cancer who benefit from Avastin. But Patricia Keegan, MD, director of the FDA's division of biologic oncology products, said at the news conference that the four clinical trials submitted to the FDA offer no hint about which women might benefit.