LONDON, Jan. 7 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7January2026) approved the medicineNirogacestathydrobromide (Ogsiveo)for the treatment ofprogressing desmoid tumours in adults.
Desmoid tumours are tumours that form inconnective tissue in the body, usually the arms, legs or abdomen.Whilst they arenot cancerous,astheygrow,theycancause damage in nearby tissueand become difficult to remove.
Nirogacestathydrobromideworks by inhibitingthe activity of certain proteinswhich are involved in the growth of the tumours.Studies have shown that patients takingnirogacestathydrobromidebenefitted fromliving longerwithout their condition getting worseand avoiding the need for potential surgery.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Patient safetyis our top priority.
The approval ofnirogacestathydrobromidewillbenefitadults with desmoid tumours, improvinghealth and quality of life.
As with all licensed medicines, we will continue to monitor its safety and effectiveness closely.
The most common side effectsof takingnirogacestat hydrobromide include diarrhoea, rash, nausea (feeling sick), tiredness, hypophosphataemia (low blood levels of phosphates), headache,andstomatitis (inflammation of the lining of the mouth).A serious side effect can be premature menopause, which may affect more than 1 in 10 people.
Nirogacestathydrobromide may cause harm to an unborn baby if taken during pregnancy. It is uncertain how it may damage ovaries and testicles, andhow it may affect men and women's fertility. Therefore,nirogacestathydrobromide must not be taken during pregnancy, and highly effective contraception must be used.
A patient card will be provided to support pregnancy prevention in female patients takingnirogagestathydrobromide, and in female partners of male patients taking this drug. The card contains important information on the risks and the measures that must be followed to minimise potential harm.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.
Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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The approval was granted on 7 January 2026 under the International Recognition Procedure (IRP). The Reference Regulator was the European Medicines Agency (EMA)EMEA/H/C/006071/0000.
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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.
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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.
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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 newscentre@mhra.gov.uk or call 020 3080 7651.
Disclaimer: Curated by HT Syndication.
