Fianlimab Medicine 04 December 2025 Extended indication Fianlimab in combination with cemiplimab for first line treatment of locally advanced or metastatic unresectable melanoma in adolescents, adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Fianlimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Fianlimab in combination with cemiplimab for first line treatment of locally advanced or metastatic unresectable melanoma in adolescents, adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Regeneron Portfolio holder Regeneron Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks LAG-3 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials 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 De trial is nog gaande. Duration of treatment Frequency of administration Dosage per administration References NCT05352672 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