Romvimza

Adults with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection may worsen functional limitation or cause severe morbidity.

30 mg orally once daily until disease progression or unacceptable toxicity. Take with or without food. For CYP2C9 poor metabolizers: 30 mg every other day.

Tablets: 30 mg

None listed in the prescribing information.

• Hepatotoxicity: ALT/AST elevations reported. Monitor liver function tests prior to and during treatment.
• Embryo-Fetal Toxicity: Can cause fetal harm. Verify pregnancy status before initiating.

Periorbital Edema (32%), Increased AST (28%), Increased ALT (25%), Fatigue (22%), Hair Color Changes (20%), Increased Creatinine (18%), Dizziness (14%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Strong CYP2C9 Inhibitors: Avoid coadministration or reduce dose.
CYP2C9 Inducers: Avoid; may reduce vimseltinib efficacy.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Vimseltinib is a selective inhibitor of colony-stimulating factor 1 receptor (CSF1R), reducing tumor-associated macrophage infiltration and tumor burden in tenosynovial giant cell tumors.

Tmax: 2-4 hours. Protein binding: >99%. Metabolized primarily by CYP2C9. Half-life: ~17 hours.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• MOTION — Vimseltinib vs placebo in TGCT. Phase III, n=121.
  🔬 NCT05059262 ↗

Romvimza has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: