Romvimza(vimseltinib)

Romvimza (vimseltinib) is indicated for the 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. The recommended dose is 30 mg. The marketing authorisation application was submitted on 29 June 2024, and the drug received a positive opinion from the CHMP on 24 July 2025, with an approval date of 14 February 2025.

In efficacy studies, the objective response rate (CR+PR) per RECIST v1.1 at Week 25 for vimseltinib was 39.8% (95% exact CI: 29.2, 51.1), compared to 0% (95% exact CI: 0.0, 8.8) for placebo. The difference in objective response rate between vimseltinib and placebo was 39.0% (95% CI: 28.4, 49.6), with a CMH test p-value of <0.0001. Up to Week 25, the objective response rate for vimseltinib was 42.2% (95% exact CI: 31.4, 53.5), while for placebo it was 0% (95% exact CI: 0.0, 8.8).

Safety data from 253 participants exposed to vimseltinib showed that 100.0% experienced any treatment-emergent adverse event (TEAE), with 37.3% experiencing any TEAE with a maximum Grade 3/4. A Grade 3 urticaria was observed in 1.1% of patients. The mean treatment duration was 19.6 months.