FDA’s Pazdur Highlights Need For Unbiased Toxicity Assessments
Agency’s top oncology reviewer shares anecdote about an unidentified drug whose sponsor strongly asserted that cardiovascular toxicity seen in a single-arm study was due to the natural history of the disease. The tale bears similarities to Ariad’s troubled leukemia drug Iclusig.
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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.
The period after completion of pivotal trials but ahead of FDA approval provides an opportunity for oncology drug sponsors to conduct badly needed dose comparison trials, a multi-stakeholder panel says at the annual Conference on Clinical Cancer Research.
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.