EMA Recommends Romvimza for Tenosynovial Giant Cell Tumor

At its July 2025 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization in the European Union for Romvimza (vimseltinib, Deciphera Pharmaceuticals) to treat adults with symptomatic tenosynovial giant cell tumor  (TGCT) not amenable to improvement with surgery.

TGCT is a rare, locally aggressive neoplastic proliferation of synovial tissue in joints and tendon sheaths. While typically benign, it can cause significant morbidity, including pain, swelling, stiffness, and limited range of motion, severely impacting quality of life. For patients whose tumors are not amenable to surgical resection, effective systemic treatment options are needed to control tumor growth and manage symptoms.

The active substance of Romvimza, vimseltinib, is an oral switch-control TKI designed to selectively inhibit the colony-stimulating factor 1 receptor (CSF1R), a key driver in the pathology of TGCT. By blocking CSF1R signaling, the drug targets the overgrowth of synovial cells and inflammatory components that drive tumor development and joint deterioration.

The CHMP’s recommendation was based on results from the phase 3 MOTION study, which enrolled adults with symptomatic, unresectable TGCT. In the study, the objective response rate at week 25 was 40% for patients treated with vimseltinib compared with 0% for patients receiving placebo, as measured by RECIST criteria. Patients also reported clinically meaningful improvements in stiffness, range of motion, physical function, and quality of life.

Romvimza will be available as 14 mg, 20 mg, and 30 mg capsules.

The drug’s most common side effects include increased liver enzymes, periorbital edema, increased cholesterol, rash, increased creatinine, decreased neutrophils, fatigue, face edema, pruritus, peripheral edema, and hypertension.

The CHMP concluded that the benefits of Romvimza outweighed the risks in this patient population, fulfilling an unmet medical need in those for whom surgery is not a viable option.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published on the EMA website after the marketing authorization has been granted by the European Commission.