A historic moment for patients with tenosynovial giant cell tumors.
For the first time in Europe, a drug has been approved for the treatment of tenosynovial giant cell tumors (TGCT) in adults. The drug is Vimseltinib (brand name: Romvimza). This is a major breakthrough for patients who previously relied almost entirely on surgery.
TGCT is a rare, benign but often highly disruptive condition that develops in or around joints. The tumor is not malignant, but it can cause pain, swelling, stiffness, and permanent joint damage, leading to significant limitations in daily life. Surgery is usually the first option, but the likelihood of recurrence is high, especially for the diffuse form of TGCT. For patients who cannot undergo surgery, treatment options have been very limited until now.
About Vimseltinib (Romvimza)
Vimseltinib works by blocking the CSF1 receptor, a protein involved in TGCT growth. The drug is taken orally in tablet form.
The European Commission’s approval is based on the results of the international MOTION phase 3 study. In this trial, patients with TGCT who could not undergo surgery received either vimseltinib or a placebo.
Key study results:
- 40% of patients receiving vimseltinib showed a significant reduction in tumor size after 25 weeks.
- In the placebo group, this was 0%.
- Patients taking vimseltinib also experienced less pain and stiffness, improved joint mobility and higher quality of life.
- Side effects were generally manageable, according to the researchers.
A new treatment option
This is the first drug in Europe officially approved for TGCT. For patients and their families, it represents an important new treatment opportunity and improved quality of life.
More information can be found via the link below or downloaded here .
A breakthrough for fellow patients with giant cell tumors.