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FDA Medication Tracker

← All approvals · Cancer · 2025

Romvimza (vimseltinib)

The FDA approved Romvimza (vimseltinib) on February 14, 2025 to treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
Brand name
Romvimza
Generic name
vimseltinib
FDA approval date
February 14, 2025
Approved use (FDA wording)
To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity
Company
Deciphera Pharms
Application
NDA219304
Dosage form / route
CAPSULE · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

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. ROMVIMZA is a kinase inhibitor 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. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.