MHRA approves Romvimza for tenosynovial giant cell tumour

pharmafile | August 20, 2026 | News story | |  MHRA, Romvimza, tenosynovial giant cell tumour 

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Romvimza (vimseltinib) for adults with tenosynovial giant cell tumour (TGCT) when the condition affects their movement or surgery is not an option.

TGCT, a rare, non-cancerous tumour that develops around joints and tendons, usually affects a single joint, most commonly the knee or ankle and can cause pain, swelling, stiffness and difficulty with movement.

Romvimza works by blocking proteins involved in the growth of the tumours, helping to slow their progression.

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Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.

“The approval of vimseltinib provides a new treatment option for patients with TGCT who have symptoms but are unsuitable for surgery.”

The capsule is taken twice a week, with or without food, is subject to additional monitoring and it is advised, should not be used during pregnancy.

Among the most common side effects are tiredness, swelling around the eyes, ankles and feet, itching, rashes, high blood pressure and changes in liver enzyme, cholesterol, creatinine and white blood cell levels. The MHRA said more than one in five people may be affected.

Beach added that the MHRA will continue to monitor closely the safety of vimseltinib, “as with all products”.

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