OK, the incidence of already well documented side effects is more pronounced in some areas after 24 months as compared to the 11 month numbers.
Is this really unexpected, that there would be a larger percentage after prolonged treatment? ... and actually, isnt it a good thing that the population is actually around to have side effects increase 3.8 %?
BTW: The incidence rate of the arterial thrombotic events when normalized to duration of treatment exposure has not increased (10.0 events/100 patient-years in the original analysis and 9.6 events/100 patient-years in the current analysis).
The Company is implementing the following actions in its Iclusig clinical development program:
Patient enrollment in all clinical studies of Iclusig is being paused, and subject to agreement with the FDA, will be resumed with anticipated changes in dose and other modifications. In concert with this action, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig.
Patients who are currently receiving Iclusig in clinical trials will continue on therapy. Reductions in Iclusig dose from 45 mg daily will be implemented on a trial-by-trial basis for patients whose Iclusig treatment is ongoing.
The dose of Iclusig in patients who are currently enrolled in the EPIC trial will be reduced to 30 mg daily unless they have achieved a major molecular response or reach one in the future, in which case the dose will be further reduced to 15 mg daily. The Data Monitoring Committee of the EPIC trial has endorsed these changes.
The eligibility criteria for Iclusig clinical trials will be modified to exclude patients who have experienced prior arterial thrombosis resulting in heart attack or stroke.
The PACE trial data demonstrate continued efficacy after dose reduction. Of 270 chronic-phase patients in the pivotal study, 190 patients dose reduced to either 30 mg or 15 mg. Of 110 (58%) ...