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Iclusig Experience Reflects Regulatory Risk Inherent With Accelerated Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA reviewers and outside experts discussed at length concerns about cardiovascular and other adverse events in the single-arm PACE trial but believed ponatinib’s impressive efficacy in a difficult-to-treat leukemia population warranted bringing the drug to market. Sales of the tyrosine kinase inhibitor were halted less than 11 months later as safety and dosing concerns continued to pile up.

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