ARTICLE | Regulation
Rashomon effect
Avastin: FDA lags EMA decision in breast cancer; both lag physician practice
July 11, 2011 7:00 AM UTC
While FDA has been haggling with Genentech Inc. for a year - and counting - over whether to remove metastatic breast cancer from Avastin's label, the rest of the world is moving on. EMA has made a decision to keep bevacizumab and doctors in Europe and the U.S. have already started to adjust their prescribing habits by giving the drug to a narrower population of patients.
Last month, six members of FDA's Oncologic Drugs Advisory Committee confirmed a 2010 ODAC vote, voting unanimously on June 29 to back a proposal by the Center for Drug Evaluation and Research to withdraw accelerated approval for Avastin in first-line HER2-negative metastatic breast cancer...