Epcoritamab Medicine 04 December 2025 Extended indication Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Epcoritamab Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Current proprietary name Already available biosimilars / generics Proprietary name Tepkinly Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: T‑celgerichte bispecifiek antilichaam Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP No Submission date November 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Verdere resultaten dienen afgewacht te worden om een uitspraak over de therapeutische waarde te doen. Duration of treatment Frequency of administration Dosage per administration References NCT05409066 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://iknl.nl/kankersoorten/hemato-oncologie/nkr-cijfers/fl Additional remarks In Nederland krijgen jaarlijks zo’n 550 mensen de diagnose folliculair lymfoom (FL). Een deel daarvan komt later in tweedelijns behandeling (2L).De geschatte totale prevalentie ligt rond de 5.600 patiënten. Expected cost per patient per year Cost € < 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 https://www.formularywatch.com/view/unique-new-lymphoma-treatment-priced-at-37-500-monthly Additional remarks In de Verenigde Staten kost epcoritamab $37,500 per maand. De kosten zullen dus erg afhangen van de behandelduur. Bij een behandeling van zes tot twaalf maanden zal de prijs ongeveer tussen de €200.000 en €400.000 zijn. De prijs in Nederland is nog niet bekend. 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