FDA Revokes Approval Of Avastin For Treatment Of Breast Cancer
November 22, 2011
The Food and Drug Administration (FDA) Commissioner, Margaret Hamburg, announced last Friday that the agency has revoked its approval of the drug Avastin for treatment of breast cancer patients. KSDK 5 News reported last week that Hamburg confirmed the decision was made based on a lack of evidence that the drug improves patient survival rates on top of the serious side effects the drug may have.
Avastin received “accelerated approval” in 2008 for the treatment of breast cancer after the drug’s manufacturer, Genentech, Inc., cited promising results found in a 2005 early clinical study of the drug. The FDA required that Genentech to provide a double blind study with results showing improved survival rates of patients. Unfortunately, the results of the study found patients taking the drug had lower survival rates. Patients treated with placebo and Taxotere, another cancer drug, lived for 31.9 months on average; whereas patients treated with Avastin and Taxotere lived for 30.8 months at a low Avastin dose and 30.2 months at a high Avastin dose.
The drug is also known to have a serious side effect known as Gastrointestinal (GI) perforation, a condition in which a hole develops in the stomach, small intestine, or large intestine. Symptoms include pain, nausea, vomiting, and could result in death.
The Missouri Drug Injury Lawyers with Cofman Townsley encourage patients to research any drugs their doctor recommends them to take before starting a regimen of medication. If you have suffered from a drug injury, contact a lawyer immediately to evaluate your case.