Out for Avastin against breast cancer
Out for Avastin for breast cancer in the US
11/21/2011
The US Food and Drug Administration (FDA) finally withdrew its approval for Avastin for breast cancer treatment last Friday. This decision is difficult for the manufacturer Roche. Nevertheless, the group is confident. He now wants to expand his market further in China and Latin America. In addition, the drug is still approved for colorectal, lung, kidney and brain cancers in the United States.
US Food and Drug Administration criticizes missing studies
Avastin was originally positioned by the subsidiary Genentech as a breast cancer (breast) cancer drug. Now the FDA considers the use of the drug in this area unsuitable. The agency justifies its decision with a lack of studies showing the success of the drug in breast cancer.
In Europe, the use of Avastin in breast cancer therapy is assessed very differently. While the drug in the US is no longer approved for this area, the European Medicines Agency (EMA) has expanded the use of the active ingredient bevacizumab (trade name: Avastin) in breast cancer therapy.
The group does not give up
Roche is now in the counter-offensive and plans further studies for next year, which should expand the range of indications for Avastin. The group wants to apply for approval of the drug for ovarian cancer therapy in the US. He has already done that in Europe. The drug is one of the biggest hopes of the group. According to its own statements, however, the company would not reduce jobs because of the refusal to grant breast cancer in the US. (Ag)
Also read:
Testing of Roche cancer drug extended
Picture: Andrea Damm