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 Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Multiple Myeloma
Extended indication In Patients With Relapsed and/or Refractory Multiple Myeloma.
Manufacturer CARsgen
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2022
Expected Registration 2023
Registration phase Clinical trials
Additional remarks Primary completion datum in december 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Plaatsbepaling ten opzichte van andere behandelingen is nog niet in te schatten.
References LUMMICAR STUDY 1 (NCT03975907)

Expected patient volume per year

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

There is currently nothing known about the expected cost.

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.