except one time that I can recall with GLFD, but the vote on benefit was much closer (one negative, the other one narrowly positive) on that one; Gliadel was already on the market at the time of the panel recommendation and they were going for expansion of indications from recurrent to upfront.
With 2 really strong votes of 13-0 and 11-3, this looks like a slam dunk for final approval.
Can anyone recall any other positive ODAC votes/recommendations that were not followed?
The jury is stil out on Iressa (especially given the additional safety concerns out of Japan), but these votes should make it hard for the FDA not to approve it. Beware though, the FDA can drag their feet with actually approving it and the label and post-marketting commitments may be substantial. True, Rituxan has sold $1billion/year, but it doesn't have the toxicity and dosing inconvenience that Bexxar likely will. Also, Rituxan had no competition and is chimeric, Bexxar is behind Zevalin and Rituxan and needs to worry about the development of anti mouse antibodies is it tries to move into an earlier stage of the disease.
Be happy, this is an important hurdle, but the FDA can always play more games.
TTP D B
Was wondering about the discussion on the long term response data, or question # 3, and how it was resolved? Was it a matter of more data needed or was it deemed not relevant to vote on or necessary for the registration process? Any color on what was said over this? Who (FDA; ODAC; or Corixa) suggested the question be withdrawn?
Interesting to note the obstacles that CRXA has to face now that they have a positive response from ODAC. These are probably the same people who were saying why ODAC would shoot down the application.
The panel DID NOT TAKE a formal vote. Why not? They could have easily taken the vote and passed the results on to FDA...but they DID NOT VOTE FORMALLY.
UPDATE - US FDA panel backs Corixa's Bexxar for lymphoma
Tuesday December 17, 6:52 pm ET
(Adds detail, background)
BETHESDA, Md., Dec 17 (Reuters) - A U.S. advisory panel on Tuesday said the experimental cancer drug Bexxar, developed by Corixa Corp. (NasdaqNM:CRXA - News) and Britain's GlaxoSmithKline Plc (London:GSK.L - News), had benefits in treating non-Hodgkin's lymphoma.
The Food and Drug Administration advisory committee did not take a formal vote on Bexxar, which is aimed at helping non-Hodgkin's lymphoma patients whose disease has relapsed or become resistant to other treatment."