Extended indication Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Int
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Lisocabtagene maraleucel
Domain Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi.
Proprietary name Breyanzi
Manufacturer Celgene
Mechanism of action CAR-T therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date June 2022
Expected Registration July 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03575351

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 390,504.00
References Drugs.com
Additional comments De Nederlandse prijs is nog niet bekend. Op basis van de US-prijs zijn de kosten voor Breyanzi per behandeling: € 390.504. Dit middel is in de sluis geplaatst tot er een financieel arrangement overeengekomen is.

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.