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Poor Quality Data On Immune-Related Adverse Events Slowed Yervoy Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Questions surrounding immune-mediated adverse events with Bristol-Myers Squibb’s Yervoy (ipilimumab) and how these risks should be conveyed to practitioners proved problematic in FDA’s review of the breakthrough treatment for metastatic melanoma, leading to a three-month delay in approval.

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