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Drugs

Mirdametinib: First Approval

Published in:
Author
Sheridan M. Hoy
Published in
Drugs | Issue 7/2025

Abstract

Mirdametinib (GOMEKLITM) is an oral small molecule inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) developed by SpringWorks Therapeutics for the treatment of neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (PN). It is the first therapy to be approved for the treatment of both adults and children with NF1-associated PN in the USA, where it is indicated for use in adult and paediatric patients 2 years of age and older with NF1 who have symptomatic PN not amenable to complete resection. A marketing authorisation application for mirdametinib in NF1-PN is currently under review in the EU. Clinical studies of mirdametinib for the treatment of paediatric low-grade glioma are ongoing. This article summarizes the milestones in the development of mirdametinib leading to this first approval.
Title
Mirdametinib: First Approval
Author
Sheridan M. Hoy
Publication date
27-05-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 7/2025
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02190-0
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