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.
You may also be interested in...
Bristol Expands Immunotherapy Footprint With Anti-PD-1
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.”
Review Of Reviews: Drug Review Profiles Of 2011
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.
Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval
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.