Igrelimogene litadenorepvec Medicine 05 December 2023 Extended indication Treatment of solid tumor patients (melanoma and SCCHN) refractory to or progressing after Anti-PD(L) In combination with avelumab Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Igrelimogene litadenorepvec Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Treatment of solid tumor patients (melanoma and SCCHN) refractory to or progressing after Anti-PD(L) In combination with avelumab Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Tilt Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Unknown Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date 2024 Expected Registration 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT05222932 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) IKNL 2022; (2) Simeone E, Ascierto PA. Anti-PD-1 and PD-L1 antibodies in metastatic melanoma. Melanoma Manag. 2017 Dec;4(4):175-178. doi: 10.2217/mmt-2017-0018. Epub 2017 Nov 21. PMID: 30190923; PMCID: PMC6094668. Additional remarks Melanoom van de huid betreft 8.045 patiënten in 2022 (1) 60 tot 70% van de patiënten met gemetastaseerd melanoom reageert niet op Anti-PD therapie (2). Ongeveer 25% van de patiënten met gemetastaseerd melanoom die een response hadden op anti- PD therapie heeft recurrence (2). Voor Plaveiselcelcarcinoom van de huid betreft 14.873 patiënten in 2022 (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 Unknown Indication extensions References Additional remarks Other information Additional remarks