Optimizing the Dosing Regimen of Cetuximab and Ramucirumab Using the Model‐Informed Drug Development Paradigm

作者：Lan Ni, Azhar Khan, Amanda Long, Ling Gao, Nikki Toms, Elena González-Gugel, Susan Holsmer‐Brand, Yong Lin, Paolo Abada, Sandra Dickin, Declan O’Dea, Ran Wei, Min‐Hua Jen, Himani Aggarwal · 发表于：Clinical Pharmacology & Therapeutics · 年份：2023 · DOI：10.1002/cpt.2919 · 被引用次数：6 · 研究领域：Colorectal Cancer Treatments and Studies、Statistical Methods in Clinical Trials、Cancer Genomics and Diagnostics

Model-informed drug development (MIDD) is a process that integrates drug exposure-based, biological, and statistical models to enhance the benefit-risk balance in drug development. The US Food and Drug Administration (FDA) MIDD Paired Meeting Pilot Program provides a platform to apply MIDD approaches to drug development and to seek regulatory feedback in a collaborative and streamlined process prior to submission for approval. Eli Lilly and Company (Lilly) participated in the Pilot Program to seek agency alignment to enhance the initial approved dosing regimens of cetuximab (Erbitux; Eli Lilly and Company, Indianapolis, IN) and ramucirumab (Cyramza; Eli Lilly and Company) without conducting additional clinical trials. Here, we describe the overall MIDD strategy at Lilly, the process with the FDA, and the impact of implementing the approach.