Deciphera Receives Approval for ROMVIMZA™ (vimseltinib) in Tenosynovial Giant Cell Tumour (TGCT)
Thursday, September 18, 2025
Deciphera Pharmaceuticals has received approval from the European Commission (EC) for ROMVIMZA™ (vimseltinib) to treat adult patients with symptomatic tenosynovial giant cell tumour (TGCT) in the European Union.
TGCT is a rare, locally aggressive disease linked to changes in the CSF1 gene, causing excess CSF1 production and accumulation of CSF1R-positive inflammatory cells. The condition leads to joint pain, swelling and reduced mobility. While surgery remains the main treatment, recurrence is common, particularly in diffuse TGCT, and repeated procedures may result in disability. For patients without surgical options, treatment choices have been limited, making this new approval an important development.
The therapy is indicated for patients experiencing impaired physical function where surgery is not feasible or would lead to serious complications or disability.
This marks the first approved therapy for TGCT in Europe. The decision was based on results from the Phase 3 MOTION study and earlier Phase 1/2 trials, which showed significant benefits in range of motion, physical function, pain management and quality of life compared with placebo.
Complete responses were also observed in some patients, and the safety profile was consistent with earlier findings.
Source: deciphera.com
