Extended indication Adult patients with relapsed or refractory large B-cell lymphoma.
Therapeutic value No estimate possible yet
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.
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2021
Expected Registration December 2022
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 75 µg/kg
References NCT04384484
Additional comments 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

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 172,000.00
References Drugs.com
Additional comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.