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Iclusig Experience Reflects Regulatory Risk Inherent With Accelerated Approval

 
• By Sue Sutter

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.

Rather than representing a failure of FDA’s accelerated approval process, Ariad Pharmaceuticals Inc.’s halt in sales of its leukemia drug Iclusig (ponatinib) due to increasing rates of cardiovascular-related adverse events should be a reassuring sign to industry that the agency is willing to take calculated risks when faced with an efficacious drug.

That FDA requested ponatinib come off the market pending a benefit/risk re-evaluation less than 11 months after accelerated approval might...

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