Emactuzumab Medicine 04 December 2025 Extended indication Emactuzumab monotherapy for first line treatment of localized or diffuse Tenosynovial giant cell tumour in adolescents, adults and elderly where surgical removal of the tumor is not viewed as an option. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Emactuzumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Extended indication Emactuzumab monotherapy for first line treatment of localized or diffuse Tenosynovial giant cell tumour in adolescents, adults and elderly where surgical removal of the tumor is not viewed as an option. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer SynOx Portfolio holder SynOx Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: gehumaniseerd monoklonaal antilichaam dat zich richt op het colony stimulating factor 1 receptor (CSF1R). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2026 Expected Registration August 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chirurgie, radiotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn op dit moment nog geen resultaten bekend. Duration of treatment Average 24 week / weeks Frequency of administration 1 times every 2 weeks Dosage per administration 1.000mg per infusie References NCT05417789 Additional remarks Expected patient volume per year Patient volume < 683 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks Volgens het Integraal Kankercentrum Nederland (IKNL) ligt de incidentie van tenosynoviale gigantcel tumoren (TGCT) in Nederland rond de 34 gevallen per miljoen inwoners per jaar voor gelokaliseerde TGCT, en ongeveer vijf gevallen per miljoen inwoners per jaar voor diffuse TGCT. Gezien een bevolking van circa 17,5 miljoen mensen komt dit neer op ongeveer 595 nieuwe gevallen van gelokaliseerde TGCT en circa 88 nieuwe gevallen van diffuse TGCT per jaar. Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks