Extended indication Cervical dysplasia caused by human papillomavirus (HPV) types 16 and 18.
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Bizalimogene ralaplasmid
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Cervical dysplasia caused by human papillomavirus (HPV) types 16 and 18.
Manufacturer Inovio
Mechanism of action Immunostimulation
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Werkingsmechanisme: Gene transference; Immunostimulants. Fabrikant: Inovio.

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chirurgie
Therapeutic value Possibly no place in the treatment regimen
Substantiation De fase 3 data van REVEL 1 wijst uit dat in de actieve arm bij 24% regressie van high grade laesies plaatsvindt ten opzichte van 11% in placebo arm. Standard of care is op dit moment chirurgie met regressie in 75% van de patiënten. Chirurgie is effectiever gebleken, er zal dus naar verwachting geen plaats in de behandelrichtlijn zijn.
Frequency of administration 1 times a day
Dosage per administration 1 ml
References NCT03185013
Additional comments 1 milliliter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Expected patient volume per year

Patient volume

< 600

Market share is generally not included unless otherwise stated.

References WHO, IKNL
Additional comments Cervicale dysplasie is een premaligne afwijking (dysplasie) van de cellen van de baarmoederhals. IKNL: 841 patiënten met cervixcarcinoom in 2018. WHO: HPV types (16 and 18) veroorzaken 70% van baarmoederhalskankers. De verwachting is dus dat maximaal 600 patiënten in aanmerking komen.

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 Yes
Indication extensions Phase II: Anal intraepithelial neoplasia; Human papillomavirus infections; Vulvar intraepithelial neoplasia
References Adis Insight
Additional comments Mogelijk zal deze behandeling wel een meerwaarde hebben voor mannen met een HIV infectie. Op dit moment loopt er een fase 2 studie.

Other information

There is currently no futher information available.