Romvimza FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 17, 2025.
FDA Approved: Yes (First approved February 14, 2025)
Brand name: Romvimza
Generic name: vimseltinib
Dosage form: Capsules
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Tenosynovial Giant Cell Tumor
Romvimza (vimseltinib) is a switch-control kinase inhibitor of colony stimulating factor 1 receptor (CSF1R) for the treatment of patients with tenosynovial giant cell tumor.
- Romvimza is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
- Tenosynovial giant cell tumor (TGCT) is a rare, non-malignant tumor that develops inside or near the joints. It is caused by a dysregulation in the colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of CSF1R-positive inflammatory cells into the lesion. Although benign, the tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint.
- Romvimza works in the treatment of TGCT by selectively and potently inhibiting CSF1R.
- FDA approval was supported by data from the pivotal Phase 3 MOTION study, where Romvimza met the primary endpoint of improved objective response rate (ORR) compared to placebo, and all key secondary endpoints with statistically significant and clinically meaningful improvements in quality-of-life measures, and a well-tolerated safety profile.
- Romvimza capsules are administered orally twice weekly, with a minimum of 72 hours between doses.
- Warnings and precautions associated with Romvimza include hepatotoxicity, embryo-fetal toxicity, and increased serum creatinine.
- Common adverse reactions (incidence ≥20%), include periorbital edema, fatigue, rash, peripheral edema, face edema, and pruritus.
Common laboratory abnormalities include increased AST, increased cholesterol, decreased neutrophils, decreased leukocytes, and increased ALT.
Development timeline for Romvimza
Further information
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