Jodium (131I) omburtamab Medicine 08 December 2020 Extended indication Neuroblastoma Central Nervous System/Leptomeningeal Metastases in patients up to 18 years. Therapeutic value Possible added value for a subgroup Total cost Registration phase Negative CHMP opinion Product Active substance Jodium (131I) omburtamab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Neuroblastoma Central Nervous System/Leptomeningeal Metastases in patients up to 18 years. Current proprietary name Already available biosimilars / generics Proprietary name Omblastys Manufacturer Y-mAbs Therapeutics Portfolio holder Mechanism of action Immunostimulation Route of administration Intracerebral Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antibody-dependent cell cytotoxicity. (Het antilichaam 8H9 werkt door zich te richten op B7-H3 of CD276 receptoren die aanwezig zijn op kankercellen, waardoor radioactief gemerkt jodium de tumoren doodt). Fabrikant: Y-mAbs Therapeutics. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date May 2021 Expected Registration Orphan drug Yes Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Primary completion datum fase 3 studie in december 2020. Negatieve CHMP opinie december 2022. Therapeutic value Current treatment options chirurgie, radiotherapie en chemotherapie Therapeutic value Possible added value for a subgroup This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt verwacht dat omburtamab mogelijk gegeven zal worden in het geval van CNS involvement. Dit is overigens zeldzaam bij neuroblastoom. Het Europese protocol schrijft tot nu toe MIBG voor. Duration of treatment Average 5 week / weeks Frequency of administration Dosage per administration References NCT03275402. Additional remarks Een behandelcyclus van 131I-omburtamab duurt 5 weken en omvat een dosimetrische dosis. Patiënten krijgen maximaal twee cycli intracerebroventriculaire 131I-omburtamab. Expected patient volume per year Patient volume 2 - 3 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References prinsesmaximacentrum Additional remarks In Nederland krijgen elk jaar ongeveer 25 kinderen een neuroblastoom. Er wordt verwacht dat er jaarlijks 1 tot 2 patiënten die CNS involvement hebben in aanmerking zullen komen voor behandeling met 131I-omburtamab. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Meningeal carcinomatosis; Peritoneal cancer; Soft tissue sarcoma. References Adisinsight. Additional remarks Fase 2 studies. Other information Additional remarks