Extended indication 2L Follicular Lymphoma
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Epcoritamab
Domain Hematology
Reason of inclusion Indication extension IND
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication 2L Follicular Lymphoma
Proprietary name Tepkinly
Manufacturer Abbvie
Portfolio holder Abbvie
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2026
Expected Registration 2027
Orphan drug No
Registration phase Clinical trials
Medicine sluice Broadly excluded

Therapeutic value

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.
References NCT05409066

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

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

Potential total cost per year

Off label use

Indication extension

Other information