I just got off this call. It was regarding the FDA action to revoke approval for Avastin for breast cancer. There was no discussion on TDM1, however there was discussion that was somewhat helpful on how to impact and/or participate in the appeal hearing process as Genentech appeal the decision.
The appeal process is Gene has 15 days to submit a request for hearing, then 30 days to submit documentation. Then the FDA decides whether to allow a hearing. If a hearing is granted, it is a public meeting chaired by the FDA.
There is a process to get comments on the docket for this, login info for this is:
log into
www.regulations.gov
then enter in search
FDA-2010-N-0621.
This takes you to a page with the document sent by the FDA to Genentech and also has sections to add a comment.
This was good information, and the Genentech participants emphasized that interested parties should take this opportunity to comment, as this becomes part of the official public record and part of the proceedings.
They really need patients and advocates to be vocal - and this was a recurring theme I also heard at San Antonio. That clinicians and researchers and pharmceutical co's are limited in what they can say. But as patients we are not.
So, some good information, not on TDM1 topic at all...