Follow-up studies of the medication show it failed to slow tumor growth or extend patient lives.
The Food and Drug Administration had granted the drug accelerated approval on the condition that later studies showed a survival benefit, but additional studies submitted by the manufacturer failed to show Avastin significantly extended lives compared to chemotherapy alone.
The FDA also concluded that other data does not confirm the tumor shrinkage seen in earlier studies.
Next week, a panel of outside experts will review the evidence on Avastin.
The agency has the option of removing the drug's approval for breast cancer.