Extended indication In Patients With Relapsed and/or Refractory Multiple Myeloma.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Zevorcabtagene autoleucel
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Multiple Myeloma
Extended indication In Patients With Relapsed and/or Refractory Multiple Myeloma.
Manufacturer CARsgen
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Yes
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion datum in december 2022. Heeft wel een weesstatus in de Verenigde Staten.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Substantiation Plaatsbepaling ten opzichte van andere behandelingen is nog niet in te schatten.
References LUMMICAR STUDY 1 (NCT03975907)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Additional remarks Gezien de vele behandelopties komen naar schatting maximaal 50 patiënten per jaar hiervoor in aanmerking. Naar de toekomst toe kan CAR-T mogelijk naar eerdere behandellijnen verschuiven, in dat geval zouden meer patiënten in aanmerking komen.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information