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 No registration expected 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 Philogen Portfolio holder Mechanism of action Immunostimulation Route of administration Intratumoral Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Nidlegy is een combinatie van immunocytokines bifikafusp alfa (L19IL2) en onfekafusp alfa (L19TNF). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2024 Expected Registration November 2025 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Teruggetrokken in juli 2025. 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 Er is geen officiële publicatie Pivotal studie en NoDreams inclineert nog tot 2026. PIVOTAL study NCT02938299: The primary outcome analysis shows an HR between the RFS of the treatment and control arm of 0.59 [95% CI 0.41-0.86; log-rank p=0.005] as per BICR assessment and 0.61 [0.41-0.92; p=0.018] as per investigator assessment (power = 85%; two-sided α = 0.05). Median RFS was 16.7 mo. in the treatment and 6.9 mo. in the control arm as per BICR. Nog geen resultaten van NeoDREAM studie. De plaatsbepaling is nog onduidelijk door wijziging adjuvante behandeling gedurende de loop van de studie. Duration of treatment Average 4 week / weeks Frequency of administration 1 times a week Dosage per administration References NCT03567889 (NeoDREAM); NCT02938299 (Pivotal) 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 (1); expertopinie (2) Additional remarks Melanoom van de huid en lip betreft in totaal 7.670 patiënten in 2021. Dit betreft 695 patiënten in stadium 3 en 83 in stadium 4 (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