Extended indication Metastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Ilixadencel
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Kidney cancer
Extended indication Metastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy
Proprietary name Intuvax
Manufacturer Immunicum
Mechanism of action Other, see general comments
Route of administration Intratumoral
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Fabrikant Mendus. Werkingsmechanisme: pro-inflammatoir allogeen dendritisch celvaccin. Het doel van het vaccin is om de autologe dendritische cellen van een patiënt te laden met hun eigen tumorantigenen, in vivo, om een immuunrespons tegen tumorcellen te stimuleren.

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Sunitinib
Therapeutic value No estimate possible yet
Substantiation Eerdere studies van vergelijkbare geneesmiddelen in mRCC waren tot nu toe negatief. Er is op dit moment nog niets te zeggen over de mogelijke meerwaarde.
Duration of treatment Average 3 week / weeks
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mln cellen/dosering
References MERECA NCT02432846
Additional comments Twee ilixadencel doses (10 miljoen cellen/dosis) met een tussenpoos van 14 dagen vóór nefrectomie, gevolgd door behandeling met sunitinib na nefrectomie volgens de klinische praktijk tot aan ziekteprogressie of het einde van de studie (78 weken na screening).

Expected patient volume per year

Patient volume

< 52

Market share is generally not included unless otherwise stated.

References NKR2020 (1);
Additional comments Stadium 4 niercarcinoom betreft 529 patiënten (1).

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 combination with pembrolizumab in multiple solid tumor indications, Liver cancer; Gastrointestinal stromal tumours (Phase 1/2)
References SPS UK, AdisInsight

Other information

There is currently no futher information available.