Iclusig Returns To Market With Smaller Patient Population, Stronger Warnings
This article was originally published in The Pink Sheet Daily
FDA approves new labeling that narrows the indication for Ariad’s leukemia drug to largely the third-line and later setting.
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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.
Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.
Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.