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Luvometinib: First Approval

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Abstract

Luvometinib (复迈宁®), a highly selective orally administered mitogen-activated protein kinase kinase 1/2 (MEK1/2) inhibitor, is being developed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Fosun Pharma) for the treatment of rare malignancies and other rare diseases associated with abnormal mitogen-activated protein kinase (MAPK) activation. In May 2025, luvometinib was approved in china for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms and for the treatment of paediatric patients aged ≥ 2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This article summarizes the milestones in the development of luvometinib leading to this first approval for the treatment of adult patients with LCH/histiocytic tumours and children and adolescents aged ≥ 2 years with NF1 with symptomatic, inoperable PN.
Title
Luvometinib: First Approval
Author
Susan J. Keam
Publication date
02-08-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 9/2025
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02217-6
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