For the second time in two years, a panel will go before the FDA's Center for Drug Evaluation and Research (CDER) to fight for the fate of the drug Avastin for breast cancer patients. In July of 2010, Avastin lost its right as a therapy to treat advanced, or metastatic, breast cancer when an advisory panel voted 12-1 to withdraw the drug. Four clinical studies concluded that the drug did not make patients live longer. Furthermore, the studies found that Avastin resulted in dangerous side effects, including increased risk of internal bleeding and high blood pressure (Hellerman).
Avastin's maker, Genentech, immediately filed an appeal before the FDA Commissioner Margaret Hamburg could finalize the decision. The law that created the "accelerated approval" process, which the drug was approved under, allowed for the appeal. Despite the ongoing battle, many doctors are already opting not to prescribe Avastin, according to Charlotte Arnold, a Genentech spokeswoman. Only 20-25 percent of new breast cancer patients receive the drug, down from the former 60 percent before the panel voted (Hellerman). .
The accelerated approval program began in 1992 so patients waiting for new, promising treatments could receive medicine earlier. Four cancer therapy drugs, all approved under the accelerated system, have been withdrawn by the companies who make them. These drugs include Ethyol used to prevent kidney damage in patients receiving chemotherapy, Celebrex used for polyps in the colon, Mylotarg used by older leukemia patients, and Iressa (Hellerman). .
In 2004, Avastin was first introduced as cancer therapy because of its ability to restrict blood flow to tumors. The drug was originally used for cancer of the lung, kidney, colon, and brain, but was granted provisional approval to treat breast cancer in 2008. Two studies showed that Avastin increased the length of time that women went without their symptoms getting worse.
