Tasadenoturev

Active substance Tasadenoturev
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen 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

Product

Manufacturer DNAtrix
Mechanism of action Oncolytic adenovirus
Therapeutical formulation Injection
Additional comments 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)
Particularity New medicine with Priority Medicines (PRIME)
Orphan drug Yes
Registration phase Clinical trials
Additional comments Dit geneesmiddel is geclassificeerd als een ATMP.

Therapeutic value

Current treatment options Chirurgie, radiotherapie, chemotherapie
Therapeutic value No judgement
Duration of treatment one-off
Dosage per administration 1.0 mL

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

Additional comments 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

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 No

Other information

There is currently no futher information available.