Daromun Medicine 05 December 2023 Extended indication Neoadjuvant intratumoral treatment in clinical stage IIIB/C melanoma Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Daromun Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Neoadjuvant intratumoral treatment in clinical stage IIIB/C melanoma Current proprietary name Already available biosimilars / generics Proprietary name Nidlegy Manufacturer Sun Pharma Portfolio holder Mechanism of action Immunostimulation Route of administration Intratumoral Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2024 Expected Registration October 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03567889 Therapeutic value Current treatment options Er is nog geen vergelijkbare behandeloptie als standaardzorg beschikbaar. Ook darleukin fibromun komt mogelijk snel op de markt. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten uit de fase 3 studie zijn nog niet bekend. Duration of treatment Average 4 week / weeks Frequency of administration 1 times a week Dosage per administration References NCT03567889, NCT02938299 Additional remarks Expected patient volume per year Patient volume < 778 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2021 Additional remarks Melanoom van de huid en lip betreft in totaal 7.670 patiënten in 2021. Dit betreft 695 patiënten in stadium III en 83 in stadium IV (1). Enkel patiënten met operabele ziekte komen in aanmerking. Daarnaast zullen niet alle patiënten die chirurgisch behandeld worden ook dit geneesmiddel krijgen (2). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks