LONDON, Aug. 14 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (14 August 2026) approvedvimseltinib(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 rarenon-canceroustumourthat forms aroundajoint andtendons. It usually affects a single joint, most often the knee or ankle of young and middle-aged adults.It can causesymptoms such aspain, 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 ofvimseltinibprovides a new treatment option for patients with TGCTwhohavesymptoms butareunsuitable for surgery.
"As with all products, we willcontinue to keep the safety ofvimseltinibunder close review."
The active ingredient inRomvizma,vimseltinib,helps slow the growth of TGCTs by blocking the proteins that cause these tumours to grow.
This medicine is subject toadditionalmonitoring and should not be used in pregnancy.
Vimseltinibis a capsule that should be swallowed whole with water and with or without food, twice a week.
The most common side effects ofvimseltinib (which may affect more than 1 in5people) include, tiredness, swelling around the eyes, ankles and feet, itching, rashes, high blood pressure, increased levels of liver enzymes, increased levelsofcholesterol,increased levelsofcreatinine, and decreased white blood cell levels (neutrophils).
Patients should takevimseltinibexactly 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 theYellow Card scheme.
Notes to editors
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Thenew marketingauthorisationwasgranted on14 August 2026 to Deciphera Pharmaceuticals.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.
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This product wassubmittedand approved via the International Recognition Procedure (IRP) Route B.
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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating 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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact thenewscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
