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.

FDA placed 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.