Vimseltinib

Vimseltinib (Romvimza, Deciphera Pharmaceuticals (Netherlands) B.V.) has 1 EU-approved indication in 1 tumour type.
Approved indications of Vimseltinib
Biomarker requirementRegimenSettingConditions
Tenosynovial giant cell tumour1
None
Monotherapy
Any line
Symptomatic; clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability
Full text of section 4.1 (therapeutic indications)

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.

Label history

There is no record of changes to the Romvimza label that oncolabels can read yet. EMA publishes it some months after the first approval.