[ot] Ralph Moss: Avastin: Stunning Reversal - Part II

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BlankAvastin: Stunning Reversal - Part II

Avastin was given a preliminary approval for breast cancer based on early

studies that did not include survival data. The advisory committee agreed

unanimously that two new trials failed to confirm the impression of benefit of

the earlier studies. In particular, use of Avastin failed to prolong overall

survival in the women who received it. In one study, the drug delayed tumor

worsening by one month. In simple terms, Dr. Loehrer, Sr. of Indiana

University (and a panel member) said, " It just delays by another visit before

they get the news that their tumor progressed. "

An FDA panel had voted in December 2007 by a 5-4 vote to recommend against

approval. But the FDA commissioner of the time, C. von Eschenbach, MD,

then overruled his own panel (something that's almost never done) and approved

the drug....a decision that turned out to be worth around $500-700 million per

year to Genentech.

However, FDA almost never revokes approval once it is granted. Thus, a

government report has shown that of the 90 drugs given accelerated approval not

one had been removed from the market and in fact the agency sometimes did not

make sure that follow-up studies were done. It will be an interesting test to

see how the new FDA commissioner, Margaret A. Hamburg, MD, reacts to this nearly

unanimous panel recommendation.

Ralph W. Moss, Ph.D.

Sources:

Pollack, . F.D.A. Panel Urges Limits for Avastin. New York Times, July 20,

2010.