loncastuximab tesirine Medicine 07 December 2021 Extended indication Adult patients with relapsed or refractory large B-cell lymphoma. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance loncastuximab tesirine Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Adult patients with relapsed or refractory large B-cell lymphoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2021 Expected Registration December 2022 Orphan drug Unknown Registration phase Registration application pending 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 Duration of treatment Frequency of administration Dosage per administration 75 µg/kg References NCT04384484 Additional remarks Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m^2 Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m^2 Q3W for up to 6 additional cycles. 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 € < 172,000.00 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 Drugs.com Additional remarks In de VS kost 1 injectie $24.500 (€21.500). De klinische studie geeft aan dat een behandeling bestaat uit maximaal 8 cycli met 1 injectie per cyclus. Dit zou in totaal op €172.000 neerkomen. De prijs in de EU zal mogelijk lager uitvallen. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks