Version 1

Tasadenoturev

Medicine

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
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
Manufacturer DNAtrix
Mechanism of action Oncolytic adenovirus
Route of administration Unknown
Therapeutical formulation Injection
Budgetting framework Unknown
Additional remarks Nieuw mechanismr: 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
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Fase 2 klinische studies.

Therapeutic value

Current treatment options EMA: "At the time of designation, several medicines were authorised for the treatment of glioma in the EU. Treatments included surgery, radiotherapy (treatment with radiation), and chemotherapy (medicines to treat cancer) to improve survival. Patients also received treatments for the symptoms of glioma, including corticosteroids to reduce pressure within the skull and medicines to prevent seizures."
Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Substantiation EMA: "The sponsor has provided sufficient information to show that the medicine might be of significant benefit for patients with glioma because early studies showed a good response in patients whose disease came back after standard treatment. This assumption will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status."
Dosage per administration 1.0 mL

Expected patient volume per year

Patient volume < 500

Market share is generally not included unless otherwise stated.
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

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions No

Other information