Mistakes are the portals of discovery.
James Joyce
In a wise reversal, the FDA will now allow two hours of open public testimony during the first day of the (June 28-29) Avastin hearing.Smart.
In further news, ODAC will vote on the fate of Avastin's breast cancer indication at the agency's hearing on the proposed withdrawal of the claim, marking the third time in four years that the panel has been formally polled on whether the VEGF inhibitor should be used in this population. It voted against approval the previous times.
The announcement that ODAC will have a voting role contrasts with CDER’s original expectation that committee members would be asked to provide advice and recommendations but not vote.
Karen Midthun explains that since this is an administrative hearing, procedures will differ from those of a typical advisory committee meeting and may bear more resemblance to a court case.
According to Karen, "It may help to think of this as, in some ways, like a trial." Representative and will lead the meeting. Panel members will have an opportunity to question witnesses appearing on behalf of Genentech and CDER.
"As with a typical advisory committee meeting, we will ultimately ask you to vote as a committee on the issues that are the subject of the hearing," the letter states. "There will not be an immediate decision by FDA at the hearing. Instead, as with an advisory committee meeting, FDA will consider the committee's input and will announce its own ultimate decision at a later date."
The Pink Sheet opines that, “The decision to give ODAC a voting role would seem to bode ill for Genentech in light of the panel's previous negative reviews of bevacizumab for MBC.”
But there’s a third option other than yea or nay. FDA is leaving an opening for Genentech to hold on to Avastin's metastatic breast cancer indication even if Commissioner Margaret Hamburg determines existing evidence has not demonstrated bevacizumab's efficacy or safety for this use.
Commissioner Hamburg can decide to retain bevacizumab's accelerated approval in first-line MBC while the company conducts additional studies to confirm clinical benefit even after determining that the grounds for withdrawing the claim have been met.
