2025 Approvals

ROMVIMZA(vimseltinib): A New Treatment for Tenosynovial Giant Cell Tumor Approved by the FDA on February 14 2025

Jasmine C

01 Oct 2025 — 1 min read

What is it prescribed for?

ROMVIMZA is prescribed for adults with symptomatic tenosynovial giant cell tumor (TGCT) also known as Giant Cell Tumor of the Tendon Sheath, where surgery is likely to cause worsening functional problems or serious harm.

What is the name of the drug and what does it do?

The brand name is ROMVIMZA (pronounced "rom-vim-zah"), and the generic name is vimseltinib. ROMVIMZA is designed to treat TGCT, a rare, non-cancerous tumor that forms in the joints or tendons and can cause swelling, pain, and limited movement.

How does it work?

ROMVIMZA is a kinase inhibitor that blocks a protein called CSF1R. This protein is involved in the growth of certain cells. By blocking CSF1R, ROMVIMZA helps reduce the abnormal cell growth seen in TGCT, helping to relieve symptoms like joint swelling and pain.

What did the research discover?

In a study called MOTION, patients treated with ROMVIMZA showed significantly better results compared to those who took a placebo:

40% of patients taking ROMVIMZA showed tumor shrinkage compared to 0% of those taking placebo.
Patients also had greater improvements in joint movement, physical functioning, and pain relief.
The treatment helped 48.2% of patients achieve at least a 30% improvement in pain scores without needing more pain medicine.

What are some of the side effects?

Common side effects (occurring in 20% or more of patients):

Increased liver enzymes (AST and ALT)
Swelling around the eyes
Fatigue
Rash
Increased cholesterol
Swelling in the hands, feet, and face
Itchy skin
Decreased white blood cells

What are the dosage recommendations and how is it prescribed?

ROMVIMZA is taken by mouth:

The recommended dose is 30 mg twice a week, with at least 72 hours between doses.
It can be taken with or without food.
Capsules should be swallowed whole, without opening, breaking, or chewing.
If a dose is missed by more than 48 hours, the patient should skip the missed dose and continue on the regular schedule.

Source:

Deciphera Pharmaceuticals. ROMVIMZA (vimseltinib) capsules. Prescribing Information. 2025. Available from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdf

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