FDA Avastin Hearings This Week
Some of you have been following the intense controversy about the value of avastin in the treatment of metastatic breast cancer. If this is new to you, the brief summary is that the FDA, in 2008, gave it fast track approval based on some early studies. As more data became available, it was evident that avastin did not extend life and came with serious, even life-threatening, side effects for some women. Therefore, the FDA retracted the approval for its use in metastatic breast cancer (it is approved for use in some other cancers). The pharma company, Genentic, naturally was quite unhappy about this decision as were some physicians and patients who were doing well with the drug.
This week, under a lot of pressure, the FDA is holding hearings to consider the decision. Here is a report from the American Cancer Society:
Tuesday and Wednesday, July 28-29, the Food and Drug Administration (FDA) is holding a hearing on the use of the drug bevacizumab (Avastin®) for the treatment of advanced breast cancer. The FDA granted conditional approval for the use of Avastin on breast cancer patients in 2008. In July 2010, after reviewing the results of four additional clinical studies of Avastin in women with breast cancer, an FDA advisory committee concluded that the drug does not prolong overall survival or improve quality of life, and recommended the removal of Avastin as an approved treatment for advanced breast cancer. In December 2010, the FDA began the process of removing Avastin as a recommended treatment for metastatic breast cancer.
Genentech, the manufacturer of Avastin, took the unusual step of requesting an FDA hearing to present more evidence on the effectiveness of the drug in treating metastatic breast cancer. The FDA scheduled a hearing today and tomorrow in response to Genentech's request.
For more information on the FDA's decision, please refer to several blog posts by Dr. Len Lichtenfeld, national American Cancer Society Deputy Chief Medical Officer: