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ariadndndough

04/03/13 10:53 AM

#28333 RE: Monday1 #28331

BIOMAVEN
To: ariadough who wrote (2489) 4/3/2013 10:48:45 AM
From: Biomaven of 2490

There is a clear disconnect between this level of side-effects and what was reported in both the Phase I and Phase II trials, even for blast and accelerated phase patients. So I'm not quite sure how to resolve that discrepancy, assuming of course this report is indeed accurate.

Are these new patients sicker than those enrolled in the trials? Seems unlikely to me.

One possibility is that in the trial doctors were quicker to lower the dosage to 30 mg or even less. That would suggest that a lower starting dose might be better in practice - that's what INCY has done now for their JAK drug.

Ultimately, as I've been saying since the label, Iclusig is likely to remain mostly 3rd-line until we get some more safety data from earlier-stage patients.

Peter