Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval
This article was originally published in Pharmaceutical Approvals Monthly
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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Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
FDA and Bristol-Myers Squibb went to great lengths to ensure that interim overall survival data from a first-line study of Yervoy (ipilimumab) could be reviewed by the agency in a manner that maintained the trial’s blind.