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

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 approache...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2023-07, Vol.114 (1), p.77-87
Main Authors: Ni, Lan, Khan, Azhar Zaman, Long, Amanda, Gao, Ling, Toms, Nikki, Gonzalez‐Gugel, Elena, Holsmer‐Brand, Susan, Lin, Yong, Abada, Paolo, Dickin, Sandra, O'Dea, Declan, Wei, Ran, Jen, Min‐Hua, Aggarwal, Himani
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal, Humanized
Cetuximab
Drug Development
Humans
Pharmaceutical Preparations
Ramucirumab
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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.2919