With Iclusig’s Return, Ariad Gets A Second Chance To Get The Dose Right
In allowing ponatinib back on the market, FDA is requiring the sponsor to address a gap in the original development program – failure to identify the optimal dose. However, Ariad is also looking at the post-marketing requirements as a step in the pathway to use in earlier treatment settings.
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Covis seeks to discuss study proposals and other accelerated approval precedents at still-unscheduled withdrawal hearing; CDER says company’s current RWE proposal is inadequate given its design and the failure of the PROLONG confirmatory clinical trial.
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.