Extended indication Neuroblastoma Central Nervous System/Leptomeningeal Metastases in patients up to 18 years.
Therapeutic value Possible added value for a subgroup
Registration phase Clinical trials

Product

Active substance 131I-omburtamab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other oncology
Extended indication Neuroblastoma Central Nervous System/Leptomeningeal Metastases in patients up to 18 years.
Manufacturer Y-mAbs Therapeutics
Mechanism of action Immunostimulation
Route of administration Intracerebral
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments 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
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional comments Primary completion datum fase 3 studie in december 2020.

Therapeutic value

Current treatment options chirurgie, radiotherapie en chemotherapie
Therapeutic value Possible added value for a subgroup
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
References NCT03275402.
Additional comments 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.

References prinsesmaximacentrum
Additional comments In Nederland krijgen elk jaar ongeveer 25 kinderen een neuroblastoom. Er wordt verwacht dat er jaarlijks 1-2 patiënten die CNS involvement hebben in aanmerking zullen komen voor behandeling met 131I-omburtamab.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Meningeal carcinomatosis; Peritoneal cancer; Soft tissue sarcoma.
References Adisinsight.
Additional comments Fase 2 studies.

Other information

There is currently no futher information available.