Tenosynovial giant cell tumour

The EU has approved 1 indication of 1 drug in tenosynovial giant cell tumour. None of them needs a biomarker result.

Line of therapy

Approved indications, Tenosynovial giant cell tumour
DrugBiomarker requirementRegimenSettingConditions
No biomarker required1
Vimseltinib
Romvimza
None
Monotherapy
Any line
Symptomatic; clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability
Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Vimseltinib (Romvimza)
    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.