Vimseltinib — Active Pharmaceutical Ingredient

Vimseltinib (1 brand name, 1 dosage form, 1 route)

Available dosage forms: CAPSULE.

Routes of administration: ORAL.

Brand Names

• ROMVIMZA

Indications and Usage

ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Contraindications

None.

Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions (5.1)]

Mechanism of Action

Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.