From David Miller's article
On May 9 and 10, ODAC meets in DC. On May 9, a superficially similar NDA for a drug from pink sheet company DOR BioPharma (DORB) called orBec will be in front of the committee. Despite potentially compelling efficacy data, I believe Dr. Pazdur will take out his “Provenge frustration” on orBec.
David used certain terms to make Dorb chances worse than they are and denegrate the company.
a pink sheet company is even lower than the bulletin board but that is how he termed it
Using the term superficially similar also denegrates orbec data. there is nothing similar about the data. Orbec's data is much stronger. It isn't even close
data comparison
The patients on provenge lived for a bit over 24 months and the patients on placebo lived for a bit over 20. The best thing you can say about Provenge is that it is safe and doesn't cause side effects. You could say the same about water as long at you don't drown yourself in it.
On intention-to-treat analysis, oral BDP was associated with 37% and 45% reductions in the risk of GVHD-treatment failure at study day 50 and at 30 days follow-up, respectively. The corresponding risk reductions among patients eligible for the prednisone taper at day 10 were 61% and 62%.
By day 200 after transplantation, 5 BDP-treated patients had died compared with 16 control patients, a risk reduction of 67% (p = 0.03). The reduction in mortality risk with BDP was even more pronounced among subjects who had received unrelated and HLA-mismatched stem cells -- 91% (p = 0.02). The survival benefit was still apparent 1 year after randomization.
Another important factor is the numbers above are very much the same as the results observed in Orbec's phase 2 trial. This means it would be hard to prove that the great data seen in the orbec trial was a statistical anomaly. Dendreon's Provenge has no such data. they have changed their endpoints around so much it can make you dizzy.
So as far as I see, to say the data is superficially similar shows that he is not giving orbec the credit it is due and the fact that he was right about the panel meeting is more a fact that he was lucky to have people on the panel that were looking more at the the risk than the benefit part of the risk benefit profile
Another thing is not only does orbec have great efficacy but it actually reduces side effects. As you know prednisone is very toxic, so removing it from the regiman improves quality of life
to be very honest I am very upset that he mentions Dor in the way he did.
One more thing is many oncologists are trying to make a slurry of Orbec themselves and giving it to their patients because they know the benefit. the problem is this gives the immediate release part of the treatment but not the extended release part. These doctors will probably testify at the meeting. The fda usually likes to control that sort of thing.
Beclomethasone is an already approved drug and new formulations of already approved drugs have a higher success rate on approvals than new molecular entities
David, stick it
AI
