The Food and Drug Administration on November 18, 2011 ruled that Avastin should no longer be used to treat advanced breast cancer patients as the risks such as severe high blood pressure, bleeding, heart attack, or heart failure, perforations in kidney outweigh the benefits for the metastatic breast cancer patients. FDA Commissioner Dr. Margaret Hamburg said that she had arrived at the decision after much thought and with heavy heart. Avastin is world's best-selling cancer drug, and also is used to treat colon, kidney, lung and brain cancers. The FDA gave Genentech, the manufacturer of Avastin and part of the Swiss conglomerate Roche Group, in 2008 to market the drug under a special permit while the advanced studies and trial were continuing.
However, two new studies published in the January 26, 2012, New England Journal of Medicine, show that Avastin may be helpful for the early-stage cancer-stricken women. In one study, about one-third of women given Avastin plus chemotherapy for few months prior to surgery have no cancer vs. 28 percent of the women in the control group given chemotherapy alone. In the second study, tumors disappeared for the 18 percent of the women in the experimental group (Avastin plus Chemo) vs. 15 percent of the women in the control group. The true test is whether Avastin helps improve survival. Women in Control and Experimental Groups in both studies are under continuing watch for that pattern to emerge.