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Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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