FDA Revokes Avastin Approval

Approval for Avastin as Breast Cancer Drug Revoked

On Friday, November 18, 2011, the commissioner of the U.S. Food and Drug Administration (FDA) announced that the approval for the usage of Avastin, generic name bevacizumab, as a treatment for metastatic breast cancer was officially revoked. It was cited by the commissioner that the drug had not been proven at all to help in lengthening the life of patients taking Avastin to help treat breast cancer and had not shown to help improve the quality of their life. Instead, it had been linked to serious and life-threatening health concerns such as bleeding, heart attack or failure, high blood pressure and perforations in the stomach and intestines.

Initially approved in 2004 for the treatment of certain metastatic cancers and later in 2008 for the treatment of metastatic breast cancer, the drug has failed to perform in the clinical trials following the accelerated approval program. Following the accelerated approval, the drug's manufacturer Genentech performed several small clinical studies and submitted them to the FDA; however, the results of these studies were not enough to justify the approval and the FDA's Center for Drug Evaluation and Research (CDER) requested that the approval for treatment of breast cancer be removed from the drug's label.

Suffering from Avastin? Contact a medical injury attorney!

While Avastin will still be available on the market and maintains approval for the treatment of other types of cancers, it no longer have the breast cancer indication on its labels. Already, the drug has seen a serious dip in sales. In the first nine months of 2011, the drug's sales fell 15% domestically and 8% globally. For those who have already taken the drug for a treatment and have suffered serious and adverse side effects as a result, there could be grounds to file a claim. Manufacturers have a responsibility to place safe and tested drugs onto the market - if their hastiness to turn a profit resulted in serious injuries or illness to you, you should not be forced to suffer in silence without any source of relief.

We at Arnold & Itkin, LLP strongly believe in advocating for the rights of victims. By working with an experienced pharmaceutical injury lawyer from our firm, you will be able to be confident knowing that you will have an experienced attorney on your side that has the know-how and the experience to fully protect your legal rights. At our firm, we have been successful in handling some of the most complex cases and will do everything that we can to fight to maximize your overall recovery. To learn more about your case and what can be done to protect your legal rights, please do not hesitate to contact us today!

Want to know more about Avastin lawsuits? Contact Arnold & Itkin today!