427 Approval timings and review speed of immune checkpoint inhibitors (ICIs) in cancer therapy between the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) from 2010-2022

Abstract

BackgroundICIs targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1) or its ligand (PD-L1) have transformed outcomes in many cancer types. Prompt regulatory approval is essential to...