Vimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (14 August 2026) approved vimseltinib (romvimza) to treat adult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option.

TGCT is a rare non-cancerous tumour that forms around a joint and tendons. It usually affects a single joint, most often the knee or ankle of young and middle-aged adults. It can cause symptoms such as pain, swelling, stiffness and difficulty in movement.

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, 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.

“As with all products, we will continue to keep the safety of vimseltinib under close review.”

The active ingredient in Romvizma, vimseltinib, helps slow the growth of TGCTs by blocking the proteins that cause these tumours to grow.

This medicine is subject to additional monitoring and should not be used in pregnancy.

Vimseltinib is a capsule that should be swallowed whole with water and with or without food, twice a week.

The most common side effects of vimseltinib (which may affect more than 1 in 5 people) include, tiredness, swelling around the eyes, ankles and feet, itching, rashes, high blood pressure, increased levels of liver enzymes, increased levels of cholesterol, increased levels of creatinine, and decreased white blood cell levels (neutrophils).

Patients should take vimseltinib exactly as prescribed and discuss any side effects with their doctor of pharmacist.

Anyone who suspects they are having a side effect are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme.

Notes

• The new marketing authorisation was granted on 14 August 2026 to Deciphera Pharmaceuticals.
• More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
• This product was submitted and approved via the International Recognition Procedure (IRP) Route B.
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.