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European Commission approves ROMVIMZA for TGCT treatment
['John Pinching']
PharmaTimes
Vimseltinib becomes first authorised therapy for tenosynovial giant cell tumour in the EUThe European Commission has approved ROMVIMZA (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumour (TGCT) in the EU.
The decision marks the first marketing authorisation for a TGCT therapy in Europe.
Ryota Udagawa, CEO of Deciphera, said: “The European Commission’s approval of vimseltinib for TGCT is a significant milestone for Deciphera, ONO and TGCT patients across the European Union who are in need of a non-invasive treatment option.
Secondary endpoints also showed benefit across six measures including tumour response, stiffness and quality of life.
At week 97, 23% of patients receiving vimseltinib achieved complete response, with a median time to response of 11.5 months.
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