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 € 372,050,000.00 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 plus PD-1 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Volgt EUHTA Joint Clinical Assessment Therapeutic value Current treatment options Pembrolizumab, nivolumab, ipilimumab, dabrafenib/trametinib, encorafenib/binimetinib, vemurafenib/cobimetinib. Het werkingsmechansime is echter beter vergelijkbaar met Opdualag (Nivolumab + Relatlimab) dat niet vergoed wordt binnen deze indicatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De trial loopt nog. Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05352672 Additional remarks Expected patient volume per year Patient volume < 1,063 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 Additional remarks In 2022 waren er 1.063 diagnoses melanoom, stadium 3 en 4. Expected cost per patient per year Cost € 300,000.00 - 400,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Advies sluisplaatsing Opdualag. 2022; Medicijnkosten.nl Additional remarks De prijs van fianlimab is nog niet bekend. Cemiplimab (Libtayo) kost €5.835,36 (incl. BTW) voor een flacon van 350mg. Op basis van de kosten van Opdualag (ook een LAG-3/PD1-combinatie voor melanoom) zullen de kosten per patiënt per jaar mogelijk in de orde liggen van €300.000 tot 400.000. Potential total cost per year Total cost € 372,050,000.00 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