EMA — authorised 17 September 2025
- Application: EMEA/H/C/006363
- Marketing authorisation holder: Deciphera Pharmaceuticals (Netherlands) B.V.
- Local brand name: Romvimza
- Indication: Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
- Pathway: orphan
- Status: approved
The EMA approved Romvimza, developed by Deciphera Pharmaceuticals (Netherlands) B.V., for the treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration. This condition is typically resistant to surgical options, making Romvimza a valuable treatment alternative. The marketing authorisation was granted under the orphan drug pathway, which supports the development of medicines for rare diseases.