Cusatuzumab Medicine 10 December 2019 Extended indication Acute myeloïde leukemie (AML) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Cusatuzumab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication AML / MDS Extended indication Acute myeloïde leukemie (AML) Current proprietary name Already available biosimilars / generics Proprietary name ARGX-110 Manufacturer Janssen Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Cusatuzumab is ontworpen om: CD70 te blokkeren en kankercellen die CD70 tot expressie brengen te doden door: complementafhankelijke cytotoxiciteit, verbeterde antilichaamafhankelijke celgemedieerde fagocytose en verbeterde antilichaamafhankelijke celgemedieerde cytotoxiciteit en het herstel van het immuunsysteem tegen solide tumoren. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2020 Expected Registration December 2021 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q4 2020 of Q1 2021. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times every 4 weeks Dosage per administration 10mg/kg - 20 mg/kg References NCT04023526 Additional remarks Expected patient volume per year Patient volume < 774 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2017 waren er 774 patiënten met AML. 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 Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References clinicaltrials.gov Additional remarks Other information Additional remarks