More Important Commentary on the FDA's Avastin Decision

In addition to the great MPT posts by Charley Hooper and Jim Pinkerton and myself, Saturday's Wall Street Journal weighed in decisively against the FDA's decision:

The risks of Avastin are real, but they're also well-understood and manageable, especially in end-stage oncology where there are no good options. The FDA's real goal was to send a warning to the rest of the drug industry about who is in charge of drug development. The FDA withdrew Avastin's breast cancer approval last year--leading to Genentech's unprecedented appeal and a two-day trial in June. ...

In her decision denying that appeal, Dr. Hamburg concedes that there are groups of "super responders" who experience dramatic improvements when treated with Avastin. But she then says those patients don't count because "it is not possible to determine if there is some subset of patients within the population as a whole that may have had a meaningful benefit." Dr. Hamburg also concedes that Avastin may produce better results when used with different chemotherapies, but that those prospects haven't been sufficiently tested. ...

All of this suggests that Avastin should remain on the market as one treatment alternative as knowledge about the drug grows--which is all that Genentech requested in its appeal. Looking at the same studies, the European Medicines Agency (the FDA's continental equivalent) continues to approve Avastin for breast cancer. The National Comprehensive Cancer Network, a highly respected consortium of U.S. oncology programs, has four times reaffirmed its recommendation that Avastin is "an appropriate therapeutic option."

Read the whole thing.

Related Entries:

keep in touch     Follow Us on Twitter  Facebook  Facebook

Our Research

Rhetoric and Reality—The Obamacare Evaluation Project: Cost
by Paul Howard, Yevgeniy Feyman, March 2013

Warning: mysql_connect(): Unknown MySQL server host '' (2) in /home/medicalp/public_html/incs/reports_home.php on line 17
Unknown MySQL server host '' (2)


American Council on Science and Health
in the Pipeline
Reason – Peter Suderman
WSJ Health Blog
The Hill’s Healthwatch
Forbes ScienceBiz
The Apothecary
Marginal Revolution
Megan McArdle
LifeSci VC
Critical Condition
In Vivo Blog
Pharma Strategy Blog
Drug Discovery Opinion