Lifileucel Medicine 03 June 2025 Extended indication Lifileucel in combination with pembrolizumab and follow-on IL-2 for first line or later treatment of metastatic stage IIIc, IIId, or IV unresectable melanoma in adults and elderly following lymphodepletion regimen. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lifileucel Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Lifileucel in combination with pembrolizumab and follow-on IL-2 for first line or later treatment of metastatic stage IIIc, IIId, or IV unresectable melanoma in adults and elderly following lymphodepletion regimen. Current proprietary name Already available biosimilars / generics Proprietary name Amtagvi Manufacturer Iovance Portfolio holder Mechanism of action Autologous modified cell therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date March 2025 Expected Registration January 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 NCT05727904 (TILVANCE-301) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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