The Medicines and Healthcare products Regulatory Agency (MHRA) has today (14 August 2026) approved\u00a0vimseltinib\u00a0(romvimza)\u00a0to treat\u202fadult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option.\u00a0<\/p>\n
TGCT is a rare\u00a0non-cancerous\u00a0tumour\u00a0that forms around\u00a0a\u00a0joint and\u00a0tendons.\u202fIt usually affects a single joint, most often the knee or ankle of young and middle-aged adults.\u00a0It can cause\u00a0symptoms such as\u00a0pain, swelling, stiffness and difficulty in movement.\u00a0<\/p>\n
Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:\u00a0\u00a0<\/p>\n
\u201cKeeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.\u00a0\u00a0<\/p>\n
\u201cThe approval of\u00a0vimseltinib\u00a0provides a new treatment option for patients with TGCT\u00a0who\u00a0have\u00a0symptoms but\u00a0are\u00a0unsuitable for surgery.\u00a0<\/p>\n
\u201cAs with all products, we will\u00a0continue to keep the safety of\u00a0vimseltinib\u00a0under close review.\u201d\u00a0<\/p>\n
The active ingredient in\u00a0Romvizma,\u00a0vimseltinib,\u00a0helps slow the growth of TGCTs by blocking the proteins that cause these tumours to grow.\u00a0<\/p>\n
This medicine is subject to\u00a0additional\u00a0monitoring and should not be used in pregnancy.\u00a0<\/p>\n
Vimseltinib\u00a0is a capsule that should be swallowed whole with water and with or without food, twice a week.\u00a0\u00a0<\/p>\n
The most common side effects of\u00a0vimseltinib\u202f(which may affect more than 1 in\u00a05\u00a0people) include, tiredness, swelling around the eyes, ankles and feet, itching, rashes, high blood pressure, increased levels of liver enzymes, increased levels\u00a0of\u00a0cholesterol,\u00a0increased levels\u00a0of\u00a0creatinine, and decreased white blood cell levels (neutrophils).\u00a0<\/p>\n
Patients should take\u00a0vimseltinib\u00a0exactly as prescribed and discuss any side effects with their doctor of pharmacist.\u00a0<\/p>\n
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\u00a0Yellow Card scheme<\/a>.\u00a0<\/p>\n Notes to editors\u202f\u202f\u00a0<\/p>\n The\u00a0new marketing\u00a0authorisation\u00a0was\u00a0granted on\u00a014 August 2026 to Deciphera Pharmaceuticals.\u00a0<\/p>\n More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the\u00a0MHRA Products website<\/a>\u00a0within 7 days of approval.\u202f\u202f\u00a0<\/p>\n This product was\u00a0submitted\u00a0and approved via the International Recognition Procedure (IRP) Route B.\u00a0\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.\u202f All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u202f\u00a0<\/p>\n