ARTICLE | Product Development
Iclusig conundrum
Ariad thinks dose reductions of Iclusig sufficient to manage CV risk in CML
October 14, 2013 7:00 AM UTC
Ariad Pharmaceuticals Inc. thinks the increased CV risk seen at 24 months in a pivotal Phase II trial of leukemia drug Iclusig ponatinib can be managed through stricter enrollment criteria and a dose-reduction strategy.
FDAplaced a partial clinical hold on Iclusig last week, halting enrollment in all clinical trials. The hold was based on two-year follow-up data from the Phase II PACE trial that showed longer use of Iclusig was associated with increased risk of treatment-emergent serious arterial thrombotic events...