Autologous Melanoma-derived Tumor Infiltrating Lymphocytes Medicine 04 June 2026 Extended indication Ex vivo-expanded monotherapy for treatment of melanoma. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Autologous Melanoma-derived Tumor Infiltrating Lymphocytes Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Ex vivo-expanded monotherapy for treatment of melanoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Route of administration Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date March 2025 Expected Registration July 2026 Orphan drug Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Dit record bevat basisinformatie voor een niet-goedgekeurd nieuw product dat wordt beoordeeld door het EMA en waarvoor de aanvrager niet openbaar is gemaakt en/of er geen publiekelijk geregistreerde studie beschikbaar is. Therapeutic value Current treatment options Therapeutic value Substantiation De meest prominente ontwikkeling is het geneesmiddel lifileucel (handelsnaam Amtagvi), dat in de Verenigde Staten is goedgekeurd. In Nederland loopt er een aanvraag bij ZINL/IGJ voor TIL behandeling in AVL en later Radboudumc. Lifileucel lijkt veel op de TIL behandeling zoals we die in Nederland hebben (maar is net niet hetzelfde).Ook is Lifileucel in laatste lijn getest en TIL in 1e of 2e lijn. 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 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks