Tasadenoturev Medicine 12 June 2019 Extended indication Treatment of recurrent glioblastoma in patients for which a gross total resection is not possible or advisable, or for those who refuse further surgery Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Tasadenoturev Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Treatment of recurrent glioblastoma in patients for which a gross total resection is not possible or advisable, or for those who refuse further surgery Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer DNAtrix Portfolio holder Mechanism of action Oncolytic adenovirus Route of administration Unknown Therapeutical formulation Injection Budgetting framework Unknown Centre of expertise Additional remarks Nieuw mechanisme: oncolytische immunotherapieen die tumor cellen dood en een anti-tumor respons veroorzaken. Eenmalige intratumorale injectie. Indien gegeven in combinatie met pembrolizumab, moet pembrolizumab een intraveneuze dosering hebben van 200 mg, elke drie weken. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Dit geneesmiddel is geclassificeerd als een ATMP. Therapeutic value Current treatment options Chirurgie, radiotherapie, chemotherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 1.0 mL References Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks In Nederland zijn er jaarlijks ongeveer 1.100 patiënten met de diagnose glioma waarbij er ongeveer 800 de diagnose glioblastoma krijgen. Hiervan worden er tussen de 60-70% primair behandeld met chemoradiatie. Het zal dus maximaal gaan om 500 patiënten. 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 No Indication extensions References Additional remarks Other information Additional remarks