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Product Discovery & Development
Ariad thinks dose reductions of Iclusig sufficient to manage CV risk in CML
Monday, October 14, 2013
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.
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