Ilixadencel Medicine 07 December 2022 Extended indication Metastatic renal cell carcinoma - before nephrectomy followed by sunitinib post-nephrectomy Therapeutic value No estimate possible yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Intuvax Manufacturer Immunicum Portfolio holder Mechanism of action Other, see general comments Route of administration Intratumoral Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks 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) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Sunitinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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 remarks 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. Maximum patient volume for sluice References NKR2021 (1); Additional remarks Stadium 4 niercarcinoom betreft 584 patiënten (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions combination with pembrolizumab in multiple solid tumor indications, Liver cancer; Gastrointestinal stromal tumours (Phase 1/2) References SPS UK, AdisInsight Additional remarks Other information Additional remarks