In November, the FDA withdrew its accelerated approval of Avastin as treatment for metastatic breast cancer. The decision was highly anticipated since the vote by the Oncology Drug Advisory Committee (ODAC) last summer voiced near unanimous sentiment against full approval. The 70-page decision from FDA commissioner Dr. Margaret Hamburg (available at http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf) was a detailed account of the initial accelerated approval in 2008, the expectations for full approval, and the several studies whose outcomes determined the fate of Avastin. The FDA deemed the analysis sufficiently important that the decision was written in the first-person by Dr. Hamburg, a clear signal of personal accountability and authority on this. Despite this authoritative review, the Avastin story continues to stir discussion and seems unlikely to go peacefully into the night, with several areas of controversy that remain unsettled.
New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints. U.S. Government Accountability Office. Available at: http://www.gao.gov/products/GAO-09-866. Accessed November 22, 2011.
Nocera J. Why Doesn't No Mean No? New York Times. November 21, 2011. Available at: http://www.nytimes.com/2011/11/22/opinion/why-doesnt-no-mean-no.html. Accessed November 28, 2011.