FDA committee votes to withdraw bevacizumab for breast cancerBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d4244 (Published 05 July 2011) Cite this as: BMJ 2011;343:d4244
- Jeanne Lenzer
- 1New York
An advisory committee to the US Food and Drug Administration voted unanimously to withdraw approval of a top selling drug for the treatment of metastatic breast cancer.
The six member panel concluded on 29 June that bevacizumab (marketed by Genentech as Avastin) had not been shown to be either effective or safe for the treatment of breast cancer. The FDA is inviting public comment on the decision for one month before issuing a final ruling.
This unusual action comes after several surprising developments in the approval process of bevacizumab.
In February 2008 Genentech was granted “accelerated approval” to use bevacizumab to treat breast cancer. The approval relied on a key study, known as E2100, that tested paclitaxel (marketed as Taxol) alone versus bevacizumab together with paclitaxel. The decision was seen as highly unusual, because the study used a controversial primary end point of “progression-free survival.”
Ralph D’Agostino, professor of …