Vimseltinib: First Approval
Declarations
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Arnold Lee is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.
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Abstract
Vimseltinib (ROMVIMZA™) is an orally administered kinase inhibitor that targets colony-stimulating factor 1 receptor (CSF1R), which is being developed by Deciphera Pharmaceuticals. As CSF1R activity has been identified as a contributing factor for tenosynovial giant cell tumour (TGCT), treatments targeting CSF1R have been investigated. Vimseltinib received its first approval in February 2025 in the USA for the treatment of TGCT and is under development for the treatment of chronic graft versus host disease. This article summarizes the milestones in the development of vimseltinib leading to this first approval for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
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