Drug & Device News

The Food and Drug Administration (FDA) announced on Nov. 18, 2011 that it was had revoked its approval of the drug Avastin for the treatment of metastatic breast cancer. Avastin had been used in conjunction with the cancer drug paclitaxel for treating women with the type of metastatic breast cancer known as HER2 negative. This use was approved by the FDA using the accelerated approval process, but later tests and patient results showed that it only minimally slowed tumor growth, and that no correlation between the use of Avastin and greater longevity could be shown. In a release announcing the FDA's action, FDA Commissioner Margaret Hamburg said, “As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment.” However, although many women with metastatic breast cancer saw Avastin as part of their life-saving regimen of treatment, Hamburg said the FDA needed to withdraw its approval of the drug for their use because it “found after rigorous testing the side effects of Avastin were more damaging than the benefits.” These side effects include high blood pressure and hemorrhaging. Avastin remains FDA-approved for the treatment of certain types of colon, lung, kidney and brain cancers.

GSK Announces Federal Settlement