Naxitamab Medicine 04 December 2025 Extended indication Naxitamab in combination with granulocyte-macrophage colony-stimulating factor for second line treatment of high-risk Neuroblastoma in infants and toddlers, children, adolescents. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Naxitamab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Naxitamab in combination with granulocyte-macrophage colony-stimulating factor for second line treatment of high-risk Neuroblastoma in infants and toddlers, children, adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Danyelza Manufacturer Y-mAbs Therapeutics Portfolio holder Y-mAbs Therapeutics Mechanism of action MEK kinase inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingmechanisme: gehumaniseerde monoklonale antilichaam gericht tegen het GD2-antigeen. 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 Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03363373 (Study 201) Additional remarks Expected patient volume per year Patient volume 7 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Neuroblastoma. Prinses Maxima Centrum. 2025. Additional remarks De verwachting is dat jaarlijks ongeveer 25 kinderen in Nederland gediagnosticeerd worden met neuroblastoom. Van deze gevallen wordt geschat dat ongeveer 30 tot 40% als hoog-risico wordt geclassificeerd, wat neerkomt op ongeveer zeven tot tien nieuwe gevallen per jaar. Expected cost per patient per year Cost References Additional remarks 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