FDA placed far greater weight on arterial thromboembolic and other cardiovascular events seen in the Iclusig (ponatinib) pivotal trial than did sponsor Ariad Pharmaceuticals Inc. when it came to labeling negotiations leading up to the leukemia drug’s December 2012 approval.
Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals
FDA rejected two of the sponsor’s labeling proposals because they failed to adequately address safety issues seen in the PACE trial. Ariad apparently preferred to quantify in labeling only treatment-emergent adverse events that investigators attributed to ponatinib – an approach FDA disdains for single-arm studies.
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