Extended indication Treatment of glioma
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Autologous glioma tumor cell lysates
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Brain cancer
Extended indication Treatment of glioma
Proprietary name Sitoiganap
Manufacturer Epitopoietic Research Corporation
Mechanism of action Cancer vaccine
Route of administration Intrader meal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date September 2020
Expected Registration October 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De behandeling bevindt zich op dit moment in een fase 2 studie. Het is op dit moment nog te vroeg om de therapeutische waarde te bepalen.
Frequency of administration 1 times a month
Dosage per administration 250 µg/m²
References NCT01903330

Expected patient volume per year

Patient volume

< 750

Market share is generally not included unless otherwise stated.

References IKNL data
Additional comments In Nederland zijn er jaarlijks ongeveer 1.100 patiënten met de diagnose glioma waarbij er ongeveer 750 een pathologisch bevestigde diagnose glioblastoma krijgen. Voor een dergelijk vaccin zal er sprake moeten zijn van meer dan enkel een biopsie als diagnostische resectie. Over de jaren 2014-2017 is de verhouding biopt versus resectie 28,7% versus 71,3%. (215 versus 535 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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.