Lifileucel Medicine 12 June 2018 Extended indication Maliganant melanoma, advanced melanoma Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Lifileucel Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Maliganant melanoma, advanced melanoma Current proprietary name Already available biosimilars / generics Proprietary name Contego Manufacturer Iovance Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Autologous T cell therapy that utilizes tumor infiltrating lymphocytes (TILs) derived from the patient's tumor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT02360579 Additional remarks The cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Expected patient volume per year Patient volume < 661 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 661 patiënten met Melanoom stadium III en IV 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 No Indication extensions References Additional remarks Other information Additional remarks