Poor Quality Data On Immune-Related Adverse Events Slowed Yervoy Review
This article was originally published in Pharmaceutical Approvals Monthly
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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In a Phase I trial reported at ASCO, BMS’ new immunotherapeutic antibody BMS-936558 had impressive results against melanoma, renal cell cancer and non-small cell lung cancer, including the intractable squamous cell variety. The company is already testing it in combination with Yervoy to “move melanoma treatment to new heights.”
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’s approval of Bristol-Myers Squibb’s metastatic melanoma immunotherapy was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.