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FDA’s Pazdur Highlights Need For Unbiased Toxicity Assessments

 
• By Sue Sutter

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.

Unbiased evaluations of drug-related toxicity are needed in cancer clinical trials, FDA’s top oncology reviewer said at the Friends of Cancer Research/Brookings Conference on Clinical Cancer Research Nov. 7.

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