Seams like SGEN asked for regular approval, not just accelerated approval, and the FDA is taking a strong position that accelerated approval is all they should get.
All the subsequent comments on "establishing a risk/reward" needs to be taken in this context. It is the main argument the FDA is using to requite a follow-up study.
The FDA just said flat out that the only reason for even having this meeting is to discuss why an accelerated approval is needed (as opposed to regular approval).
It's over. Should be an 11-0 vote in favor
With that sentiment from the FDA (Pazdur) I think our concerns over the ALCL approval might have been too conservative. They will probably green light this indication as well.
ADC's have been validated folks. This is a big step for what will probably become the most effective way of treating many many cancers in the future. Your witnessing a biotechtopian event here, and I hardly ever bust out that word, I save it for special occassions.
Fib and others, thanks for the meeting updates, I am not able to listen, that 4 letter word (work) gets in the way but I had time to check up on the board and I really appreciate your commentary. Keep up the great work.
FDA has made it clear that the label will be for post auto-transplant patients only.
The FDA has raised questions of how well the duration of responses was measured due lack of PET scans at all points.
Accelerated will require a confirmatory study to be done.
This study MIGHT need to be STARTED before the accelerated approval is granted.
The confirmatory for the HD indication is already started, but not one for the ALCL indication.
IMO not, because the CR rate on it's own would have been sufficient (and that had a long duration).
I.E., even if they considered all the PRs of short durations "failures", the trial would still have passed.
Often the FDA is asking more abstract questions of the panel than those which directly affect the approval. In this case they might be thinking of "tweeking" future trial endpoints based on what the panel thinks.