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Lisocabtagene maraleucel

Breyanzi

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 remarks 
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.