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Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approved Bristol-Myer’s Squibb’s metastatic melanoma immunotherapy Yervoy (ipilimumab) only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

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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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