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

1. 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.

2. 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.

3. Therapeutic value

Current treatment options
Chirurgie, radiotherapie, chemotherapie
Therapeutic value
No judgement
Dosage per administration
1.0 mL

4. 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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.