loncastuximab tesirine

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

Therapeutic value	No estimate possible yet
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.

There is currently nothing known about the expected patient volume.

Cost	< 172,000.00
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.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.