CDER no evil?
Via BioCentury ...
CDER seeks to limit scope of Avastin hearing
FDA's Center for Drug Evaluation and Research said it does not believe future studies of Avastin bevacizumab are within the scope of a hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter from CDER to CBER Director Karen Midthun, who is presiding officer for the June 28-29 hearing, CDER said future studies are not relevant to the center's conclusion that currently available data have failed to confirm the safety and efficacy of Avastin for the indication. CDER argues in the letter that the topic of withdrawal should be considered separately from the topic of future clinical trials. Genentech Inc. said it is submitting a response to CDER's letter.
However, Midthun has already indicated that future trials are a topic for discussion at the hearing. If the FDA commissioner agrees data provide grounds for withdrawal, the hearing will consider whether Avastin's accelerated approval should be maintained while Genentech conducts a confirmatory trial, according to the hearing's Federal Register notice posted last week. On Monday, the Roche (SIX:ROG; OTCQX:RHHBY) unit indicated it would focus its argument on that question.
