Ono takes on Daiichi in tenosynovial giant cell tumour

Tenosynovial giant cell tumour, a benign tumour that affects around 9,000 US patients, now has a second FDA-approved therapy, Ono’s Romvimza (vimseltinib). There are questions about how many players this market can support, but Romvimza seems to have an edge over the incumbent, Daiichi’s Turalio, which sold ¥5.1bn ($34m) in the first nine months of 2024. A cross-trial comparison shows a similar benefit on overall response rate, but Ono’s asset looks more tolerable, with no black box warning for liver injury or REMS programme, unlike Turalio. Romvimza’s twice-weekly dosing schedule is also more convenient. Ono gained the CSF-1R inhibitor via its $2.4bn purchase of Deciphera, which also gave it the gastrointestinal stromal tumour treatment Qinlock. TGCT could soon become more crowded, with Merck KGaA/Abbisko’s pimicotinib recently producing the most impressive efficacy so far in its phase 3 Manuever trial. Pimicotinib also looked favourable to Romvimza on dose reductions and discontinuations; no details of filing plans have yet emerged. The only other CSF-1R-targeting project in late-stage development for TGCT, according to OncologyPipeline, is SynOx’s antibody emactuzumab, with data from the phase 3 Tangent trial expected in 2026. Meanwhile, Romvimza recently began a phase 2 trial in the bigger indication of chronic graft-versus-host disease.

CSF-1R inhibitors for tenosynovial giant cell tumour

Note: *also inhibits Kit & Flt3. Source: OncologyPipeline & product labels.