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- change in distribution of Avastin
- Posted: 2007-10-11 11:57:17 By dan r
- Dear Friends,
Today (10/11), Genentech is notifying ophthalmologists of a change to the distribution of Avastin. Beginning November 30, the drug must be ordered directly from Genentech by the physicians themselves, rather than by a compounding pharmacy. (A compounding pharmacy is one which breaks the drug down into smaller doses from the original vial and then delivers it repackaged to the physician.)
When you read about this change in the media and the blogs (and you will), understand that the new procedure will not remove Avastin from the marketplace, and it is not being initiated in order to make Avastin more difficult or expensive to obtain. Also, since hospital physicians are unaffected by the change, the current head-to-head trials of Avastin and Lucentis will not be affected. Physicians in community private practice will probably be the most affected, but it should not affect your care.
As you know, Avastin (a cancer drug) is not manufactured or approved for use in the retina. Many retinal specialists, however, are using it off-label for treatment of choroidal neovascularization, as in wet AMD and myopic MD. The main reasons for the change in distribution are 1) the FDA's concern with repackaging the drug, which allows its unintended use, and 2) expiration of 1-year contracts between Genentech and the compounding pharmacies, which temporarily allowed this procedure while Lucentis was becoming established.
If you would like to learn more about this, here is where you can read the letter being sent to physicians:
http://www.gene.com/gene/features/avastin/letter-to-physicians.jsp
I hope this will help your understanding when the news begins to break over the next few days.
Best regards,
Dan Roberts, Director
MD Support
website: www.mdsupport.org
email: director@mdsupport.org




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