I would just like to add
"The most recent of the 2 communications focused on 51 Mayo Clinic patients who participated in the original phase 1/2 ruxolitinib clinical trial and highlighted a high treatment discontinuation rate (92% after a median time of 9.2 months), primarily for loss of treatment benefit but also because of drug-associated adverse effects. " and note primary reason for discontinued treatment as loss of benefits
yeah, they cut the medicine of those patients thinking that the treatment benefit was lost, but then realized that the drug was in fact still beneficial when the disease got worse after discontinuation.
Lol. It looks like what comes around goes around. When Ym reported a positive affect on anemia it was Incyte who fired the first shot across the bow. It was unnecessary with a 2-3 year lead. All Incyte needed to do was let the trials play out. But instead Incyte chose to attack Tefferi and Pardanani directly by calling into question their methods and associations. Pay back is a b$tch. Don't be surprised if the FDA throws you a curveball. Tefferi and Mayo have a lot of clout, and now Incyte has some explaining to do. Have a great day!
All I noticed Incyte doing was pointing out that the YMI results were consistent with relief of "the anemia of inflammation." YMI was making a big deal (and pointing it out in public as a contrast with Incyte's candidate) of an advantage that Incyte management claimed, in turn, wasn't there.
Answers to the dirty little scriblers allegations:
"...we know all the data that’s in at (screed?). And the FDA knows all that data. We’ve analyzed that data upside and down; before we put the NDA in and reviewing it again after the letter appeared."
"Firstly, what it shows is that, if you don’t keep your patients on the drug, their symptoms will come back and their spleens will begin to grow again. Okay? And we’ll be able to show you, how many patients came off when, and it’ll be a fairly eye opening result for you."
"Thirdly, if you did not keep your patients on drug for any decent length of time, and then you use them as subjects for a survival curve, the results are fairly meaningless."
"...We took those cases very seriously when we designed phase III. And we designed phase III to look very closely at the possibility that there could be a withdrawal syndrome. In phase III and also, frankly, at MD Anderson, which amounts to over 400 patients who have been on the drug for a long time and for some of them who had to stop for pharmocytokinea; we found not a whiff of evidence for a withdrawal syndrome. These patients, in the beginning, were very sick patients with multiple possible causalities for what led to their clinical outcomes and complications.
Only one of which could have been, “the drug”.
However, in phase III, we looked very hard for that, and there is no evidence for it whatsoever."
"But suffice it to say, there is nothing in there that is unknown to the FDA or to us; and there is nothing in there that changes in any way, either the efficacy or the safety profile of the drug."
the only thing the Tefferi's evidence shows us is that ruxo is effective against MF and should not be stopped unless it has to be because of adverse effects (and only in very rare cases you end up having to stop the treatment).
This was published via the NIH site; so somehow, our little "friends" at work here have some significant reach and are trying to shove this under the nose of the FDA as arduously as they can.
Obviously, timing counts as well (it seems to be done for the most dramtic impact JUST prior to the PDUFA date). It can only be based on the same data as they cited for the NEJM letter. They most likely held back the AE stuff for presentation here it this smaller bombing attempt.
If all of this was known to the company and the FDA back around 10/15 then it's no newer today.
The FDA is no different than other people. When you try to shove something down someone's throat a little too often, they tend to get irritated with you for that. I sure do hope that the FDA folks remember the names of Tefferi and Pardnani when it's YMI's turn to jump the FDA hurdle.
I wonder what they are holding back still for release on December 3rd?
Sounds like essentially the same thing as the NEJM letter, possibly with a little more venom. The reference to sponsor dependent analysis is a shot across the bow.
The author of a letter to NEJM has limited control of when it appears. But in the house journal, Tefferi presumably has a lot of control of timing. This looks suspiciously like an effort at lobbying FDA to put the worst possible label on ruxo.
"Our experience calls for full disclosure of the ruxolitinib withdrawal syndrome to patients with MF before initiating ruxolitinib therapy, and treatment discontinuation must be done under close physician supervision and preferably in a tapering schedule." It is not withdrawal syndrome, Tefferi you disgrace, it is the symptoms of MF getting worse because of stopping effective medicine. Drug discontinuation is under 5% in the larger phase III trials and not different than the placebo group.
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